Wednesday, December 30, 2009

Many diabetic foot amputations are preventable

It costs $1,400 to cover the oozing sore on the diabetic's foot with a piece of artificial skin, helping it heal if patients keep pressure off that spot. So when Medicare paid for the treatment but not the extra $100 for a simple walking cast to protect it, an artificial skin maker last year started giving free casts to some needy patients.

Without the right cushioning, "the person will walk to the bus stop and destroy it," fumes Dr. David G. Armstrong of the Southern Arizona Limb Salvage Alliance.

Limb-salvage experts say many of the 80,000-plus amputations of toes, feet and lower legs that diabetics undergo each year are preventable if only patients got the right care for their feet. Yet they're frustrated that so few do until they're already on what's called the stairway to amputation, suffering escalating foot problems because of a combination of ignorance -- among patients and doctors -- and payment hassles.

"There's no magic medicine right now for the diabetic foot," says specialist Dr. Lawrence Lavery of Texas A&M University, who bemoans that simple-but-effective preventive care just isn't attention-getting.

"People come in (saying), 'Hey, my wife noticed a bloody trail today as I was walking across the linoleum in the kitchen. What should I do?'"

President Barack Obama got a drubbing from surgeons this month after a confusing comment about how they're paid for foot amputations that cost $30,000 or more. That tab is the total cost, including hospitalization; surgeon fees range from about $750 to $1,000.

Obama's larger argument: Better payment for early-stage diabetes treatment, or even care to prevent diabetes, could save the nation money.

The money part's hard to prove but it's a lot of misery saved if it's your foot, and the spat highlights a huge problem. Some 24 million Americans have diabetes, meaning their bodies can't properly regulate blood sugar, or glucose. Over years, high glucose levels gradually damage blood vessels and nerves.

One vicious result: About 600,000 diabetics get foot ulcers every year. Poor blood flow in the lower legs makes those ulcers slow to heal. And loss of sensation in the feet, called neuropathy, makes patients slow to notice even small wounds that rapidly can turn gangrenous.

A mere nick while clipping nails, or a blister from an ill-fitting shoe, can begin the march toward amputation -- and about half of patients who do lose a foot die within five years.

Saving those feet isn't cheap. Treating a slow-to-heal diabetic foot ulcer can cost up to $8,000. If it gets infected, $17,000. Worse, a fraction of patients gets multiple slow-to-heal ulcers each year.

What helps?

--Routine foot checkups. There's great variability in how insurers pay for foot screenings before someone's deemed at high risk, says Dr. Harry Goldsmith, a consultant on podiatric reimbursement. Yet some simple tests, like one that measures blood pressure at the ankle to predict circulation clogs, can signal later risk of ulcers. Medicare patients who do develop certain risk factors qualify for the next step, regular clinic visits to have a technician trim nails or smooth calluses, time that should include a quick check for any wounds, Goldsmith says.

--Gadgets like $20 telescoping mirrors let diabetics who can't move well check their numb soles for wounds between doctor visits, and infrared foot thermometers that cost up to $100 can detect changes in temperature that mean an ulcer's brewing before the skin breaks. Again, insurance payment varies.

--Taking pressure off the foot is key, starting with supportive shoes or insoles that target weak spots before an ulcer strikes. Medicare will help pay for certain therapeutic shoes although paperwork limits the diabetics who try them, says Lavery. He finds that an athletic shoe checked by a foot specialist for proper fit can help many patients.

When an ulcer demands more advanced care like grafting that artificial skin, Armstrong says removable walking casts -- to-the-calf Velcro boots that injured athletes often wear -- ease pressure best but seldom are covered. Worried that doctors wouldn't prescribe its wound healer Dermagraft if patients crushed it before it could work, Tennessee-based Advanced BioHealing has provided nearly 1,900 of the boots through a patient-assistance program since last year, said vice president Dean Tozer.

--The "toe and flow" approach, diabetic limb-salvage teams that pair specialists who otherwise seldom work side-by-side, like podiatrists and vascular surgeons. Wound care won't work well until clogged leg arteries are cleared to improve blood flow, notes Armstrong, whose team at the University of Arizona, Tucson, documented a drop in amputations in its first nine months. Such teams can eliminate some of the time diabetics wait for appointments to treat a festering foot, plus stress prevention.

AP Online delivered by Newstex

Monday, December 14, 2009

Chronic Critical Limb Ischemia

Chronic critical limb ischemia is manifested by pain at rest, non-healing wounds and gangrene. Ischemic rest pain is typically described as a burning pain in the arch or distal foot that occurs while the patient is recumbent but is relieved when the patient returns to a position in which the feet are dependent. Objective hemodynamic parameters that support the diagnosis of critical limb ischemia include an ankle-brachial index of 0.4 or less, an ankle systolic pressure of 50 mm Hg or less, or a toe systolic pressure of 30 mm Hg or less. Intervention may include conservative therapy, revascularization or amputation. Progressive gangrene, rapidly enlarging wounds or continuous ischemic rest pain can signify a threat to the limb and suggest the need for revascularization in patients without prohibitive operative risks. Bypass grafts are usually required because of the multilevel and distal nature of the arterial narrowing in critical limb ischemia. Patients with diabetes are more likely than other patients to have distal disease that is less amenable to bypass grafting. Compared with amputation, revascularization is more cost-effective and is associated with better perioperative morbidity and mortality. Limb preservation should be the goal in most patients with critical limb ischemia.

Atherosclerosis underlies most peripheral arterial disease. Narrowed vessels that cannot supply sufficient blood flow to exercising leg muscles may cause claudication, which is brought on by exercise and relieved by rest. (For a review of the diagnosis and management of claudication, see the article by Santilli, et al., in the March 1996 issue of American Family Physician.1) As vessel narrowing increases, critical limb ischemia can develop when the blood flow does not meet the metabolic demands of tissue at rest. While critical limb ischemia may be due to an acute condition such as an embolus or thrombosis, most cases are the progressive result of a chronic condition, most commonly atherosclerosis.
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An ankle systolic pressure of 50 mm Hg or less or a toe systolic pressure of 30 mm Hg or less suggests the presence of critical limb ischemia.
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Chronic critical limb ischemia is defined not only by the clinical presentation but also by an objective measurement of impaired blood flow. Criteria for diagnosis include either one of the following (1) more than two weeks of recurrent foot pain at rest that requires regular use of analgesics and is associated with an ankle systolic pressure of 50 mm Hg or less, or a toe systolic pressure of 30 mm Hg or less, or (2) a nonhealing wound or gangrene of the foot or toes, with similar hemodynamic measurements.2 The hemodynamic parameters may be less reliable in patients with diabetes because arterial wall calcification can impair compression by a blood pressure cuff and produce systolic pressure measurements that are greater than the actual levels.

Risk Factors:
Chronic critical limb ischemia is the end result of arterial occlusive disease, most commonly atherosclerosis. In addition to atherosclerosis in association with hypertension, hypercholesterolemia, cigarette smoking and diabetes,3,4 less frequent causes of chronic critical limb ischemia include Buerger's disease, or thromboangiitis obliterans, and some forms of arteritis.5
Figure 1a
FIGURE 1A. Right heel ulcer in a 56-year-old patient with diabetes. The ulcer failed to heal after three months of conservative treatment.

Diabetes is a particularly important risk factor because it is frequently associated with severe peripheral arterial disease. Atherosclerosis develops at a younger age in patients with diabetes and progresses rapidly. Moreover, atherosclerosis affects more distal vessels in patients with diabetes; the profunda femoris, popliteal and tibial arteries are frequently affected, while the aorta and iliac arteries are minimally narrowed. These distal lesions are less amenable to revascularization. Atherosclerosis in distal arteries in combination with diabetic neuropathy contributes to the higher rates of limb loss in diabetic patients compared with nondiabetic patients.6,7

Clinical Presentation:
The development of chronic critical limb ischemia usually requires multiple sites of arterial obstruction that severely reduce blood flow to the tissues.7,8 Critical tissue ischemia is manifested clinically as rest pain, nonhealing wounds (because of the increased metabolic requirements of wound healing) or tissue necrosis (gangrene).

Ischemic rest pain is classically described as a burning pain in the ball of the foot and toes that is worse at night when the patient is in bed. The pain is exacerbated by the recumbent position because of the loss of gravity-assisted flow to the foot. Ischemic rest pain is located in the foot, where tissue is farthest from the heart and distal to the arterial occlusions.1 Patients with ischemic rest pain often need to dangle their legs over the side of the bed or sleep in a recliner to regain gravity-augmented blood flow and relieve the pain. Patients who keep their legs in a dependent position for comfort often present with considerable edema of the feet and ankles.

Non-healing wounds are usually found in areas of foot trauma caused by improperly fitting shoes or an injury. A wound is generally considered to be nonhealing if it fails to respond to a four- to 12-week trial of conservative therapy such as regular dressing changes, avoidance of trauma, treatment of infection and debridement of necrotic tissue.

Gangrene is usually found on the toes. It develops when the blood supply is so low that spontaneous necrosis occurs in the most poorly perfused tissues.

Patients with diabetes develop atherosclerotic lesions in the more distal leg vessels, which are less amenable to revascularization.
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The presence of rest pain can sometimes be difficult to discern in patients with other chronic leg pain, such as that caused by peripheral neuropathy. Labeling a wound as non-healing can also be a subjective assessment. However, a number of physical findings and objective hemodynamic parameters can be used to substantiate a diagnosis of chronic critical limb ischemia. Typical physical findings include absent or diminished pedal pulses, shiny smooth skin of the feet and legs, and muscle wasting of the calves.

An objective measurement of blood flow is easily accomplished with the use of a hand-held Doppler probe and a blood pressure cuff.1 The cuff is inflated until the pulse distal to the cuff is no longer heard by Doppler. The cuff is then slowly deflated until the pulse is again detected. This measurement is recorded as the systolic pressure. As previously mentioned, an ankle systolic pressure of 50 mm Hg or less or a toe systolic pressure of 30 mm Hg or less suggests the presence of critical limb ischemia.

University of Minnesota School of Medicine
Minneapolis, Minnesota

Peripheral Arterial Disease

Your arteries carry blood rich in oxygen and nutrients from your heart to the rest of your body. When the arteries in your legs become blocked, your legs do not receive enough blood or oxygen, and you may have a condition called peripheral artery disease (PAD), sometimes called leg artery disease.

PAD can cause discomfort or pain when you walk. The pain can occur in your hips, buttocks, thighs, knees, shins, or upper feet. Leg artery disease is considered a type of peripheral arterial disease because it affects the arteries, blood vessels that carry blood away from your heart to your limbs. You are more likely to develop PAD as you age. One in 3 people age 70 or older has PAD. Smoking or having diabetes increases your chances of developing the disease sooner.

The aorta is the largest artery in your body, and it carries blood pumped out of your heart to the rest of your body. Just beneath your belly button in your abdomen, the aorta splits into the two iliac arteries, which carry blood into each leg. When the iliac arteries reach your groin, they split again to become the femoral arteries. Many smaller arteries branch from your femoral arteries to take blood down to your toes.

Your arteries are normally smooth and unobstructed on the inside but, as you age, they can become blocked through a process called atherosclerosis, which means hardening of the arteries. As you age, a sticky substance called plaque can build up in the walls of your arteries. Plaque is made up of cholesterol, calcium, and fibrous tissue. As more plaque builds up, your arteries narrow and stiffen. Eventually, enough plaque builds up to reduce blood flow to your leg arteries. When this happens, your leg does not receive the oxygen it needs. Physicians call this leg artery disease. You may feel well and still have leg artery disease or sometimes similar blockages in other arteries, such as those leading to the heart or brain. It is important to treat this disease not only because it may place you at a greater risk for limb loss but also for having a heart attack or stroke.

What are the symptoms?
You may not feel any symptoms from peripheral artery disease at first. The most common early symptom is intermittent claudication (IC). IC is discomfort or pain in your legs that happens when you walk and goes away when you rest. You may not always feel pain; instead you may feel a tightness, heaviness, cramping, or weakness in your leg with activity. IC often occurs more quickly if you walk uphill or up a flight of stairs. Over time, you may begin to feel IC at shorter walking distances. Only about 50 percent of the people with leg artery disease have blockages severe enough to experience IC.

Critical limb ischemia is a symptom that you may experience if you have advanced peripheral artery disease. This occurs when your legs do not get enough oxygen even when you are resting. With critical limb ischemia, you may experience pain in your feet or in your toes even when you are not walking.

In severe peripheral artery disease, you may develop painful sores on your toes or feet. If the circulation in your leg does not improve, these ulcers can start as dry, gray, or black sores, and eventually become dead tissue (called gangrene).

In extreme cases, especially if your leg has gangrene and is not salvageable, your surgeon may recommend amputating your lower leg or foot. Amputation is a treatment of last resort. Vascular surgeons usually only perform it when the circulation in your leg is severely reduced and cannot be improved by the methods discussed already. More than 90 percent of patients with gangrene who are seen by vascular specialists can avoid amputation or have it limited to a small portion of the foot or toes.

~ VascularWeb ~

Wednesday, October 14, 2009

Amputation and diabetes: How to protect your feet

Foot care is especially important if you have diabetes. Diabetes can impair blood flow to your feet and cause nerve damage. Without proper attention and care, a small injury can develop into an open sore (ulcer) that can be difficult to treat. Sometimes amputation is necessary if an infection severely damages the tissue and bone.

The good news is that with proper diabetes management and careful foot care, amputation may be preventable. Here's what you need to know about the link between amputation and diabetes — and how to keep your feet healthy.
Why does diabetes pose a risk of amputation?

Diabetes can cause two potentially dangerous threats to your feet.

* Nerve damage (diabetic neuropathy). When the network of nerves in your feet is damaged the sensation of pain in your feet is reduced. Because of this, you can develop a blister or cut your foot without realizing it.
* Reduced blood flow. Diabetes can also narrow your arteries, reducing blood flow to your feet. With less blood to nourish tissues in your feet, it's harder for sores to heal. An unnoticed cut or sore hidden beneath your socks and shoes can quickly develop into a larger problem.

Left untreated, a minor foot injury could become a serious infection — even leading to tissue death (gangrene). Severe damage might require toe, foot or even leg amputation.

~ ~

The diabetic foot: amputations are preventable

People with diabetes are at risk of nerve damage (neuropathy) and problems with the blood supply to their feet (ischaemia). Both neuropathy and ischaemia can lead to foot ulcers and slow-healing wounds which, if they get infected, may result in amputation.

In 2000 the International Diabetes Federation endorsed the International Working on the Diabetic Foot as a Consultative Section on the Diabetic Foot. Together the organizations established goals for the future of diabetic foot care worldwide.


* to inform people of the extent of diabetic foot problems worldwide
* to raise awareness of the diabetic foot among those at risk and those in a position to take action
* to persuade healthcare decision makers that action is both possible and affordable
* to warn healthcare decision makers of the consequences of not taking action
* to inform people with diabetes of the measures they can take to prevent foot complications

Diabetes is a serious chronic disease. In 2003 the global prevalence of diabetes was estimated at 194 million. This figure is predicted to reach 333 million by 2025 as a consequence of longer life expectancy, sedentary lifestyle and changing dietary patterns. This rise is likely to bring a proportional increase in the numbers of people with diabetes complications, including problems of the foot.

Most amputations begin with a foot ulcer

Diabetic foot ulcers as a result of neuropathy or ischaemia are common. In developed countries, up to five per cent of people with diabetes have foot ulcers, and one in every six people with diabetes will have an ulcer during their lifetime. Foot problems are the most common cause of admission to hospital for people with diabetes. In developing countries, foot problems related to diabetes are thought to be even more common. Without action, global amputations rates will continue to rise.

Every 30 seconds a leg is lost to diabetes somewhere in the world

Extensive epidemiological surveys have indicated that between 40% and 70% of all lower extremity amputations are related to diabetes. This means that every 30 seconds a lower limb is lost to diabetes. The vast majority (85%) of all diabetes-related amputations are preceded by foot ulcers.

For most people who have lost a leg, life will never return to normal. Amputation may involve life-long dependence upon the help of others, inability to work and much misery. Aggressive management of the diabetic foot can prevent amputations in most cases. Even when amputation takes place, the remaining leg and the person’s life can be saved by good follow-up care from a multidisciplinary foot team.

In developed countries diabetic foot care accounts for up to 20% of total healthcare resources available for diabetes. In developing countries, it has been estimated that foot problems may account for as much as 40% of the resources available. In western countries, the economic cost of a diabetic foot ulcer is thought to be between US$7,000 and US$10,000. Where healing is complicated and amputation required, this cost may increase to as much as US$65,000 per person.

Up to 85% of amputations can be prevented

In most cases, however, diabetic foot ulcers and amputations can be prevented. Researchers have established that between 49% and 85% of all amputations can be prevented. It is imperative, therefore, that healthcare professionals, policymakers and diabetes representative organizations undertake concerted action to ensure that diabetic foot care is structured as effectively as local resources will allow. This will facilitate improvements in foot care for people with diabetes throughout the world and bring about a reduction in diabetic-foot-related morbidity and mortality.

Significant reductions in amputations can be achieved by well-organized diabetic foot care teams, good diabetes control and well-informed self care

There is strong evidence to indicate that foot care is best delivered when it is provided by a multidisciplinary team. This should closely involve the person with diabetes and his or her family, along with healthcare professionals from different specialties. Ideally the team will include a physician, a nurse, a specialist educator, a podiatrist, a surgeon, an orthotist (shoemaker) and an administrator. The podiatrist is a key member of the multidisciplinary diabetic foot team. At present there is a lack of trained podiatrists working in diabetic foot care. Mandatory minimal skills and equipment for those offering a podiatry service should be controlled to ensure that people with diabetes are not put at increased risk by unregulated, unqualified and poorly equipped practitioners.

IDF’s position is that management in the prevention and treatment of diabetic foot problems includes the following:

* Annual inspection of the foot
* Identification of the foot at risk
* Education of people with diabetes and healthcare professionals
* Appropriate foot wear
* Rapid treatment of all foot problems

Only through a multidisciplinary approach addressing the diversity of possible foot problems in people with diabetes can the desired reduction in amputation rates be achieved.


It is now time to take appropriate action to ensure that people with diabetes everywhere receive the quality of care that they deserve. It is hoped that global awareness of diabetes and its complications will be raised and that the necessary attention will be paid to the need for improved foot care for people with diabetes throughout the world.

IDF recommends that every individual with diabetes receive the best possible foot care. At the organizational level, diabetic foot care should be structured in such a way as to optimize treatment and prevention possibilities. For this to be feasible all parties involved (i.e. healthcare providers, policymakers and patient organizations) should recognize the need for combined action.

~ International Diabetes Federation ~

Prevalence of risk factors predisposing to foot problems in patients on hemodialysis

The prevalence of peripheral arterial occlusive disease (PAOD) in the general public is estimated at 3.5% to 23% (O'Hare & Johansen, 2001). Among individuals with diabetes, the prevalence of PAOD is four to seven times greater than in those without diabetes (Armstrong, Lavery, & Harkless, 1998). The most common cause of chronic renal failure is diabetes, accounting for 44.3% of new end stage renal disease (ESRD) patients annually in the United States (U.S.) and 33% of new ESRD patients in Canada (U.S. Renal Data Systems [USRDS], 2003).

Annually more than 125,000 people in the U.S. undergo lower extremity amputations (Armstrong et al., 1998). Of these, between 50% and 80% are attributable to diabetes (Lavery et al., 1996; Spollett, 1998). There is some evidence to suggest that the prevalence of foot problems among patients with diabetes who also have ESRD is even greater than in patients with diabetes without ESRD (Eggers, Gohdes, & Pugh, 1999; Hill et al., 1996; Rith-Najariah & Gohdes, 2000). Thus, the potential burden of illness in a dialysis population is a costly one. According to some sources, however, between 50% and 85% of lower extremity amputations associated with diabetes could be avoided or delayed through appropriate educational and treatment programs (Edmonds, 1987; Halpin-Landry & Goldsmith, 1999).

~ BNET ~

Preventive Foot Care in Hemodialysis Patients

Comprehensive care of hemodialysis patients poses a significant challenge for nephrologists. Although protocol driven approaches by hemodialysis centers have significantly improved standardized care, significant gaps remain in overall medical care provided to hemodialysis patients. Admittedly, with improvement in care, mortality rate for dialysis patients has decreased by 10 percent from its peak in 1988; however, it still stands at a disturbing figure of 248 deaths per 1,000 patient-years. The life expectancy of ESRD patients is one-fourth to one-sixth of the age-matched general population, with cardiovascular disease being the most likely cause of death.

Diabetics on hemodialysis have even worse prognosis than other patients. Patients with diabetes and ESRD are admitted to the hospital on average 2.3 times per year, and only 27 percent of these patients will survive five years on hemodialysis. With improvement in overall care, mortality has improved in hemodialysis patient population, but perhaps not to the expected level for multiple reasons. One likely explanation is that although mortality may be less with improvement in one area of care, mortality in other neglected areas of care may negate these potential gains. It therefore remains imperative that the nephrology community does not lose sight of the fact that only comprehensive care of these patients will realize the goal of improvement in mortality and morbidity in this hemodialysis population.
Focus on Foot Care

One such area of care which remains under the radar is morbidity and mortality related to peripheral vascular disease and foot care. For the most part, at this stage, foot care attracts attention only after a problem has already arisen. There are no screening protocols in hemodialysis centers to identify the problem earlier on. As a result, preventive strategies to reduce morbidity and mortality related to this issue remain unaddressed. The magnitude of this problem is unrealized until you add to the equation that the majority of hemodialysis patients are diabetics as well. As a result, there remains a significant issue of lower extremity amputations in hemodialysis patients. Overall, 40 percent of patients in the United States starting chronic dialysis count diabetes mellitus as the primary cause of renal failure, making it the number one cause of CKD (Berman et al., 2001).

Patients with diabetes and chronic renal disease frequently present with a combination of the devastations of diabetes including: nephropathy, retinopathy and vasculopathy. The main focus of the care of these patients has been on the target organs like heart and kidneys. Therefore, early risk factors for diabetic foot complications may be disregarded, and this may lead to amputation—a failure for both the patient and physician. Diabetic foot complications, including amputation, add significantly to the morbidity and mortality of the patient with diabetes and CKD. However, of all the long-term complications of diabetes, foot complications may be the most preventable. In the United States, diabetes is the cause of 50 percent of nontraumatic lower extremity amputations and is increasing annually (Levin, 2002). The prevalence of lower extremity amputation for patients with diabetes and CKD is much greater than those without CKD. The rate of lower limb amputation for the population at large increased during a recent four-year period from 4.8 to 6.2/100 persons. During the same time frame, this rate of lower extremity amputation rose from 11.8 to 13.8/100 among persons with CKD attributed to diabetic nephropathy. The rate for patients with diabetes and CKD was 10 times greater than the diabetic population at large (Eggers, Gohdes, & Pugh et al., 1999). The cost of treating patients with diabetes is astronomical both financially and in terms of quality of life. The loss of a lower extremity or even part of a lower extremity greatly impacts quality of life. Depression after amputation is common. Leisure activities as well as employment status are altered. The mortality rate after amputation in patients with diabetes is 11 percent to 4 percent at one year, 20 percent to 50 percent at three years, and 39 percent to 68 percent at five years (Fritschi, 2001). The impact of disorganized foot care on overall morbidity and mortality in hemodialysis patients therefore can no longer be ignored. One could always argue the benefit of putting resources into such an endeavor.

Do diabetic foot examinations reduce the risk of amputation? For two decades, the United States Department of Health and Human Services (HHS) has used health promotion and disease prevention objectives to improve the health of the American people. The overall goal for diabetes in the Healthy People 2010 objective is, “Through prevention programs, reduce the disease and economic burden of diabetes and improve the quality of life for all persons who have or are at risk for diabetes” (HHS, 2000). A specific objective contained within this goal targets a 55 percent reduction in the rate of lower extremity amputations in persons with diabetes. This would amount to 1.8 lower extremity amputations per 1,000 patients with diabetes per year, down from 4.1 per 1,000 patients that occurred in 1997 (HHS, 2000). Several clinical studies in the nondialysis diabetic population have shown that coordinated programs to screen for high-risk feet and to provide regular foot care decreased lower extremity amputation rates. In a controlled study, 45 hemodialysis patients were assigned to intensive education and care management that included preventive foot care and 38 HD patients were assigned to usual care. Over the 12-month follow-up period, there were no amputations in the study group while there were five lower extremity amputations and two finger amputations in the control group. Mortality was unaffected over the short time of the study, but the morbidity benefit was obvious. Benefit from aggressive preventive care is therefore very likely if not proven through prospective randomized controlled trials.

Nobody would disagree that regular foot care is standard care for every diabetic, and diabetic patients on dialysis are no exception to this standard of care. The American Diabetic Association recommends, “All individuals with diabetes should receive a thorough foot examination at least once yearly to identify high-risk foot conditions.” The ADA goes on to recommend more frequent evaluation for people with one or more risk factors and a visual foot inspection at every visit with a healthcare professional for diabetic patients with neuropathy. “Examination of the foot is an obvious, fundamental step to identifying certain foot risk factors that can be modified, thus reducing the risk of ulceration and amputation” (Mayfield, Reiber et al. 1998). Foot lesions are the single most frequently mismanaged problem of patients with diabetes mellitus and chronic kidney disease (CKD). Recommendations for improving the survival of patients with diabetes and CKD include improvement in the foot care and education of both patients and nephrology healthcare providers regarding diabetic foot complications (Ritz, Koch et al. 1999).
Improving Foot Care

The real question is: Why is it so difficult to provide much needed foot care and how best to do it? One has to take into account the fact that it is not easy for a hemodialysis patient to keep multiple subspecialty appointments. Once-a-year visits for foot examination are not very likely to identify and trigger an early referral. Yet three times a week they are available to a hemodialysis nurse for simple inspection and basic exam of feet. It is logical to think that foot care protocols would be part of patient care. It is possible that it poses some legal and monetary issues for the hemodialysis companies in an era of shrinking reimbursements for hemodialysis patients. These concerns, for the most part, are not true. Legally, it is always safer to prevent than treat an issue after it has been allowed to manifest in medical care set up. Improving care of hemodialysis patients with foot care should theoretically keep patients out of hospitals and on a hemodialysis chair for monetary gains of the hemodialysis center.

Finally, of course one cannot put cost on saving a patients from morbidity and mortality associated with poor foot care. However, planning this care would require careful insight into all practical aspects of care and caregivers. To begin with, the screening process should be very basic level, which hemodialysis nurses are comfortable with. Time spent and protocol has to be very straightforward. It should simply identify and focus on confirming a “NORMAL” exam from “NOT NORMAL” requires physician evaluation. Hemodialysis nurses should then be able to pass that information in a quick computerized manner to nephrologists triggering referrals to podiatrist, interventional cardiologist/interventional radiologists committed to his/her group preferably again by the same computerized network. Unnecessary time spent on telephone calls have to be avoided using protocol driven care and computerized network. Information then would have to be exchanged seamlessly between hemodialysis centre nursing staff, nephrologists, interventionalist and podiatrist. The whole network would have to be HIPAA compliant and be easy to learn and adapt to the needs to dialysis facility and physician groups involved. Ideally the network should be able to blend in with existing networks involved in hemodialysis care as well as communicate with subspecialty groups.

In summary, preventive foot care for hemodialysis patients is lost in efforts and time spent to provide care in other much politicized areas of care. But ignoring prevention in this area leads to significant morbidity and mortality. There are no randomized controlled trials of intensive education and care management versus usual care of feet in diabetic dialysis patients. Nonetheless, diabetic dialysis patients are likely to benefit from examination of the foot as part of the routine dialysis care. Given the fact that prevention can be easily done in hemodialysis center by hemodialysis nursing staff, there is little reason not to introduce it. Three times a week contact between hemodialysis nurses and patient is a potential opportunity to assess risks, educate and provide early intervention for foot issues in CKD population. Simple measures such as routine foot screening and education for this high risk population can prevent ulcer-initiating events and detect small ulcers when they may heal with proper intervention. Preventive strategies should include protocol based strategy for referral to specialist. Computerized network should allow this to happen seamlessly and effortlessly to benefit all involved in hemodialysis care. In this regard, all involved in medical care of hemodialysis patients can no longer afford to ignore the importance of preventive care of hemodialysis patients.

~ Renal Business Today ~

Zahid Ahmad, MD.
Dr. Ahmad is an assistant professor of medicine of interventional nephrology at the University of Oklahoma’s Section of Nephrology & Hypertension. For more information visit

How Do I Know if I Have Leg Ischemia?

Ischemia of the lower extremities will manifest itself in many different ways ranging from asymptomatic (simply the presence of a blockage) to gangrene of the leg or a part of it. Quite often a patient will have an asymptomatic blockage (one that they do not know is there) that is manifested simply by an absent pulse in the foot, behind the knee or in the groin or an abnormal angiogram that is usually done at the time that a cardiac catheterization (heart catheterization) is performed. A person will have no symptoms referable to this blockage and will only know of the abnormality because their physician informs them of such! This is generally referred to as Fontaine’s Class I.

The next “level” of ischemia is that of claudication. This is manifest by cramping pain that occurs with walking. It most often affects the calf muscles and generally occurs at a rather fixed distance (usually measured in blocks.) Depending on the severity of the ischemia—either by its level of lifestyle interference or by distance at which symptoms begin—it is referred to as Fontaine’s Class IIa or IIb.

Rest Pain is the next Stage (III) in the Fontaine classification of leg ischemia. This is typified by pain that occurs even in the absence of significant stress on the legs. It often occurs in the evenings awakening the patient from sleep. Quite often, hanging the leg from the side of the bed will improve the painful symptoms that are experienced. The foot will often turn a light purple or deep red-violet color as it is held in a dependent condition—often referred to as “dependent rubor.” This is a sign of significant leg ischemia and warrants aggressive intervention.

The final stage of leg ischemia (Fontaine Level IV) is tissue loss—seen as a non-healing sore or gangrene. This level (along with rest pain) is appropriately referred to as “limb-threatening ischemia” and must be evaluated appropriately by those with expertise in this area. Ignoring this degree of ischemia will very likely lead to limb loss (amputation) at some point in the future!

~ The Cardiovascular Care Group ~


Peripheral vascular disease (PVD) can affect the arteries, the veins or the lymph vessels. The most common and important type of PVD is peripheral arterial disease, or PAD, which affects about 8 million Americans. It becomes more common as one gets older, and by age 65, about 12 to 20 percent of the population has it. Diagnosis is critical, as people with PAD have a four to five times higher risk of heart attack or stroke.
~ American Heart Association ~

Peripheral Vascular Disease

What is peripheral vascular disease?

This refers to diseases of blood vessels outside the heart and brain. It's often a narrowing of vessels that carry blood to the legs, arms, stomach or kidneys. There are two types of these circulation disorders:

* Functional peripheral vascular diseases don't have an organic cause. They don't involve defects in blood vessels' structure. They're usually short-term effects related to "spasm" that may come and go. Raynaud's disease is an example. It can be triggered by cold temperatures, emotional stress, working with vibrating machinery or smoking.

* Organic peripheral vascular diseases are caused by structural changes in the blood vessels, such as inflammation and tissue damage. Peripheral artery disease is an example. It's caused by fatty buildups in arteries that block normal blood flow.

What is peripheral artery disease?

Peripheral artery disease (PAD) is a condition similar to coronary artery disease and carotid artery disease. In PAD, fatty deposits build up in the inner linings of the artery walls. These blockages restrict blood circulation, mainly in arteries leading to the kidneys, stomach, arms, legs and feet. In its early stages a common symptom is cramping or fatigue in the legs and buttocks during activity. Such cramping subsides when the person stands still. This is called "intermittent claudication." People with PAD often have fatty buildup in the arteries of the heart and brain. Because of this association, most people with PAD have a higher risk of death from heart attack and stroke.

How is peripheral artery disease diagnosed and treated?

Techniques used to diagnose PAD include a medical history, physical exam, ultrasound, X-ray angiography and magnetic resonance imaging angiography (MRA).

Most people with PAD can be treated with lifestyle changes, medications or both. Lifestyle changes to lower your risk include:

Stop smoking (smokers have a particularly strong risk of PAD).
Control diabetes.
Control blood pressure.
Be physically active (including a supervised exercise program).
Eat a low-saturated-fat, low-cholesterol diet.

PAD may require drug treatment, too. Drugs include:

medicines to help improve walking distance (cilostazol and pentoxifylline).
antiplatelet agents.
cholesterol-lowering agents (statins).

In a minority of patients, lifestyle modifications alone aren't sufficient. In these cases, angioplasty or surgery may be necessary.

Angioplasty is a non-surgical procedure that can be used to dilate (widen) narrowed or blocked peripheral arteries. A thin tube called a catheter with a deflated balloon on its tip is passed into the narrowed artery segment. The balloon is then inflated, compressing the plaque and dilating the narrowed artery so that blood can flow more easily. Then the balloon is deflated and the catheter is withdrawn.

Often a stent — a cylindrical, wire mesh tube — is placed in the narrowed artery with a catheter. There the stent expands and locks open. It stays in that spot, keeping the diseased artery open.

If the narrowing involves a long portion of an artery, surgery may be necessary. A vein from another part of the body or a synthetic blood vessel is used. It's attached above and below the blocked area to detour blood around the blocked spot.

~ American Heart Association ~

Foot Pain and Diabetes

Foot pain can certainly be caused by any number of reasons. However, foot pain resulting from diabetes is both painful and very common for those living with diabetes.

Diabetes and foot pain is generally defined by four different types.

A nerve problem (where the nerves themselves are affected by the disease) called peripheral neuropathy is the most common source of foot pain tied to diabetes. Peripheral neuropathy comes in the form of sensory, motor, and autonomic neuropathy.

Sensory neuropathy is the most common and is defined by symptoms where the amount of pain is much greater than the source that is causing the pain. As an example, just touching, or lightly pulling on your socks triggers a painful reaction. Also, with sensory neuropathy you may experience some numbness along with tingling, burning, or even stabbing type pain symptoms.

Because blood sugar can be a player in this type of pain, check your blood sugar levels for the past several weeks to see if perhaps there is an upward trend toward high levels.

Relief is of the utmost importance in these cases and can come from various applications. Massaging your feet or using a foot roller can sometimes drop the level of pain. Anything you can do from a shoe perspective such as cushioned supports and inserts can assist as well. Anything to help mitigate the pressure and pounding of daily activities on the foot and/or any rubbing or chaffing is beneficial. There are also prescription drugs that your doctor can recommend that will often times work.

When the nerves to the muscles become affected by diabetes (motor neuropathy), your muscles will begin to feel weak and achy. Although the smaller muscles of the feet aren't usually the first to be affected, your balance can eventually become affected which may cause alignment problems and/or rubbing on the feet which ultimately results in pain. Support, exercise, stretching, and massage are your best weapon against motor neuropathy. Keeping your muscles healthy and flexible is a key element in relieving this type of foot pain.

Autonomic neuropathy affects the nerves that we don't consciously control, hence the 'auto' of autonomic. With this condition existing your sweating triggers are altered and as such you may suffer from dry or cracked skin. For your feet this may result in a build up of foot calluses, thickened nails and such that lead to foot pain. The daily use of conditioning agents formulated specifically for diabetes can aid or prevent this problem.

With diabetic people proper circulation is a primary concern. Circulation problems in the feet can cause severe pain. Addressing circulation problems should always be done in conjunction with your medical doctor. Various approaches may include an exercise program, physical therapy, medication, or even surgical procedures, but again, consult with your physician before considering any strategy that involves addressing a circulation issue.

With diabetic people muscle and joint pain is not uncommon. If tendons and joints begin to stiffen coupled with imbalances associated with peripheral neuropathy and walking alignment occurs, the foot and the joints become painful. In fact, if the walking misalignments continue, this can lead to other foot disorders such as corns, bunions, and hammertoe.

People living with diabetes are more susceptible to infections within their body because of the changes that have taken place in their body. If a bacterial infection attacks the foot, the foot can become red, experience swelling, feel warm, and be painful. Keeping the immune system as healthy as possible by controlling your blood sugar, proper nutrition, and exercise, should be a top priority in your defense against infections.

If you are afflicted with diabetes, in addition to being mindful of the above information, work closely with your primary care physician to ensure that you receive proper information and care for your personal situation.

~Ezine Articles ~

Tuesday, October 6, 2009

Diabetes: PAD and Limb Loss

Peripheral Arterial Disease (PAD) and Limb Loss

Peripheral arterial disease (PAD) is a form of artheroscelorisis (hardening of the arteries). In PAD, fat builds up inside the artery (blood vessel) walls. Over time, this causes a blockage that can keep your blood from flowing properly. PAD may result in blockages in the brain, arms, kidneys, and legs.

Diabetes is a major cause of PAD. People with diabetes are unable to properly digest the sugar they eat. This sugar builds up and causes changes in their blood vessels. These changes lead to circulation problems. PAD is a risk factor for foot ulcers that can lead to amputation in diabetic patients.

How many people have PAD?

* As many as 10 million people in the United States have PAD.
* In 1996, an estimated 128,588 individuals lost a limb because of PAD.

What are the risk factors?

* Diabetes. People with diabetes are at greater risk for severe PAD. People with diabetes are five times more likely to have an amputation due to PAD.
* Age. The risk of limb loss due to PAD increases with age. People 65 or older are two to three times more likely to have an amputation.
* Gender. Men with PAD are twice as likely to undergo an amputation as women.
* Race/ethnicity. Some racial and ethnic groups have a higher risk of amputation (i.e., African Americans, Latino Americans, and Native Americans). This is because they are at increased risk for diabetes and cardiovascular disease.

~ dLife ~

Tuesday, September 22, 2009

Diabetes & Feet

Diabetes affects the body's blood circulation which in turn affects the feet. Extreme cases of nerve and foot disorders (neuropathy) may lead to foot/leg amputations also known as lower extremity amputations or LEAs.

Why do people with diabetes have to take care of their feet more than those with no diabetes? According to the American Diabetes Association by the time type 2 diabetes is diagnosed, 50% of patients already show early signs of foot complications. People with diabetes are 5 times more likely to develop "peripheral neuropathy" (nerve damage in extremities) than the general population. Checking feet daily and having a doctor examine the feet can help prevent serious complications.

What are some symptoms of peripheral neuropathy "complications"?

Loss of feeling in feet. Foot sores that do not heal. Numbness, tingling or burning sensation in feet.

How can these "complications" be prevented?

Keep blood sugar (glucose) close to your goal. Don't smoke.

Get blood pressure checked regularly. Continue taking medication for blood pressure if prescribed by your doctor.

Check feet thoroughly ever day.

Report any problems to your health care provider.

How to Care for Your Feet:

Check feet daily for cuts, sores, red spots, swelling, and infected toenails.

Keep the top and bottom of feet's skin soft and smooth by using skin cream, lotion, or petroleum jelly.

Smooth corns and calluses gently -- check with your healthcare provider for proper care.

Trim toenails each week or as needed -- Cut nails straight across and file the edges. if you cannot see well, or if your toenails are thick or yellowed, have a foot care doctor trim them.

Never walk barefoot -- wear shoes and socks (preferably cotton or wool) at all times to protect feet from injury. Remember to shake out your shoes before putting them on since a small pebble or glass can lead to foot problems.

Wear shoes that fit well. Shape of feet may change due to poor fitting shoes. If you have lost feeling in your feet ask your health care provider for advice on proper shoes.

Protect feet from extreme heat or cold

(Adapted from ADA diabetes educational material)

Monday, September 21, 2009

Diabetes and P.A.D.

What is the link between Diabetes and P.A.D.?

People with diabetes are at higher risk for having P.A.D. Some studies have found that one out of three people with diabetes over age 50 has P.A.D., and P.A.D. is even more common in African Americans and Hispanics who have diabetes.

Having P.A.D. and diabetes can be a very serious problem. People who have both diseases are much more likely to have a heart attack or stroke than those who just have P.A.D., and they are more likely to die at a younger age.

Because many people with diabetes do not have feeling in their feet or legs due to nerve disease, they may have P.A.D. but cannot feel any symptoms. As a result, they do not know they have P.A.D., or they may have it for a long time before it is diagnosed. Further, when blood flow to your feet and legs is narrowed or blocked due to P.A.D., it takes longer for cuts or wounds to heal, which may increase the risk for amputation (or losing a foot or leg).

If you have diabetes, talk with your health care provider right away if you have any of these P.A.D. warning signs:

* Fatigue, tiredness or pain in your legs, thighs or buttocks that always happens when you walk but that goes away when you rest.
* Foot or toe pain at rest that often disturbs your sleep.
* Skin sores or wounds on your feet or toes that are slow to heal.

Most people with P.A.D. do not have any symptoms. Guidelines released by leading vascular organizations recommend that people with diabetes over the age of 50 be tested for P.A.D. Testing is also recommended for people with diabetes under the age of 50 with other risk factors, such as smoking, high blood pressure or cholesterol problems. ~P.A.D. Coalition~

Encompass partners with Dialysis Clinics to secure complete diagnosis, care and treatment options for patients suffering from critical lower limb ischemia and foot wounds. The Encompass Network is a web base application that provides clinics with the tools for a thorough screening, systematic refereeing, and complete patient follow through from diagnosis to healing. Our user friendly system requires minimal staff time and the automated referring systems allow the attending physicians to review data and refer patient to a specialist based upon the patient assessment profile and easy “refer now” option. The assessment profile will keep the clinic informed with patient diagnosis, treatments and updates that go on outside of the clinic. You will see the results.

For questions, or to partner with Encompass Network Partners, contact:
Kelly Burleson, Director of Client Relations,

Wednesday, September 16, 2009

Stop PAD Petition Drive to Expand Medicare Coverage to Test Patients for Peripheral Arterial Disease

September 15, 2009 10:05 AM Eastern Daylight Time

THE SAGE GROUP Supports the “Stop P.A.D.” Petition Drive to Expand Medicare Coverage to Test Patients for Peripheral Arterial Disease

ATLANTA--(BUSINESS WIRE)--In recognition of National P.A.D. Awareness Month, Mary L. Yost, President of THE SAGE GROUP recommends that patients, relatives, and the medical community join the campaign to increase access to a simple noninvasive test to diagnose peripheral arterial disease (abbreviated P.A.D. or PAD).

This inexpensive test known as the ankle-brachial index (ABI) is a cost-effective method to detect disease in asymptomatic patients. Although Medicare currently offers testing for patients with symptoms, PAD is most commonly asymptomatic.

“Asymptomatic does not mean that the disease is benign. PAD is not just a leg problem,” declared Ms. Yost. Within 5 years, 50% of patients will experience a heart attack or stroke; 30% will be fatal.

PAD, also known as peripheral vascular disease (PVD), is characterized by a reduction of blood flow to the lower limbs due to atherosclerosis.

In the severe stages of PAD (critical limb ischemia or CLI) blood flow is so inadequate that ulcerations and gangrene occur. Once PAD has progressed to CLI, the risks of limb loss and mortality increase. At six months, approximately 20% of those with CLI will die; another 35% will experience amputation.

THE SAGE GROUP estimates that approximately 160,000 PAD-related amputations are performed annually in the U.S. “The tragedy is that early diagnosis and treatment could eliminate many of these amputations,” declared Yost.

Ms. Yost noted, “As the nation debates healthcare reform, it is important to keep in mind that early diagnosis is a key factor in reducing the costs of chronic diseases, such as PAD.”

If diagnosed in the early stages, PAD patients can be treated with the appropriate lifestyle modifications and drug therapies to reduce the risks of heart attack and stroke; exercise therapy to reduce the pain of claudication; or if blockages are more severe with minimally invasive revascularization technologies.

“However, if the disease is not diagnosed until critical ischemia occurs, interventional therapy is more costly. If gangrene is so severe that the limb cannot be salvaged the patient must undergo amputation, the most costly procedure,” Yost elaborated.

“Amputation is not only extremely undesirable from the patient’s viewpoint it is socially undesirable in terms of costs. The inability of a large percentage of these amputees to live independently adds significantly to the total cost burden,” stated Yost.

“Since the ABI test is generally not performed on asymptomatic PAD patients, significant numbers remain undiagnosed until they suffer a heart attack or develop ulcers and gangrene. In our opinion this needlessly increases overall costs,” Ms. Yost observed. “We have estimated that a 25% reduction in the number of amputations could save $2.9 billion in healthcare expenditures. Based on today’s procedure costs and long term care costs this is probably a conservative number,” she continued.

THE SAGE GROUP estimates that 16-17 million U.S. citizens currently have PAD and 2.2 to 2.7 million of them suffer from critical limb ischemia.

Additional information about PAD and vascular diseases can be found at the nonprofit Vascular Disease Foundation site at

To sign the petition, go to and complete the online form.

THE SAGE GROUP, an independent market research and consulting company, specializes in atherosclerotic disease in the lower limbs, specifically PAD (Peripheral Arterial Disease), CLI (Critical Limb Ischemia) and ALI (Acute Limb Ischemia).

Wednesday, September 9, 2009

Doctors aim to increase awareness of peripheral arterial disease

Peripheral arterial disease is one of the most common types of cardiovascular disease - and also one of the least publicized, health officials say.

According to Dr. Robert Wilkins, a board-certified cardiovascular specialist with Southern Heart Center, a service of Hattiesburg Clinic, this lack of awareness could be deadly.

During September, which is "National P.A.D. Awareness Month," Wilkins and his colleagues Drs. Craig Thieling, Ben Rester and Randel Smith, are committed to increasing the public's knowledge of this disease.

P.A.D. affects about 10 million Americans and occurs when the arteries in the legs or other non-heart arteries become narrowed or clogged by fatty deposits or plaque. The buildup of plaque causes arteries to harden and narrow, a process called atherosclerosis. When leg arteries are hardened and clogged, blood flow to the legs and feet is reduced.

The most common type of P.A.D. is the extertional leg pain, burning or tightness known as "claudication."

When not diagnosed and treated early, this may lead to a severe decrease in leg blood flow, a condition known as "critical leg ischemia," a condition that can result in a possible amputation.

P.A.D. is a warning sign that other arteries in the body, including those in the heart and brain, may also be blocked.

This condition is associated with a high risk of heart attack, stroke and death.

Unfortunately, many people may not recognize their leg pain symptoms as P.A.D.

"People were not aware of the risk factors for this disease, the increased risk for heart attack and stroke associated with this disease, or simple diagnostic tests which can identify this disease," Wilkins said. "In addition, many people are not aware of the numerous non-surgical, minimally invasive treatment options for this disease."

Southern Heart Center has now developed a special P.A.D. treatment team including: cardiovascular medicine physicians and endovascular specialists, acute care nurse practitioners, physician assistants and nurses.

Southern Heart Center also has a number of events scheduled throughout September to increase public awareness of P.A.D.

These events include speaking to senior and civic organizations, presenting at Forrest General Hospital's Spirit of Women luncheon, and working with primary care providers in this region.

The center also will sponsor three vascular disease screening events. The screenings will be provided in Hattiesburg, Picayune and Magee.

"Our cardiovascular physicians have made themselves available to speak to any organization which wants to learn more about this very serious but often treatable disease" said Ken Smith, Southern Heart Center's administrator. "They are very passionate about the need to increase public awareness of the diagnosis and treatment of peripheral arterial disease."

For more information, visit or call Southern Heart Center at 268-5800.

Tuesday, September 8, 2009

Top Warning Signs and Symptoms of Diabetes

Many of the signs of Type 1 and Type 2 diabetes are similar. In both, there is too much glucose in the blood and not enough in the cells of your body. High glucose levels in Type I are due to a lack of insulin because the insulin producing cells have been destroyed. Type 2 diabetes occurs when the body's cells become resistant to insulin that is being produced. Either way, your cells aren't getting the glucose that they need, and your body lets you know by giving you these signs and symptoms.

Frequent trips to the bathroom:

Are you visiting the bathroom much more lately? Does it seem like you urinate all day long? Urination becomes more frequent when there is too much glucose in the blood. If insulin is nonexistent or ineffective, the kidneys can't filter glucose back to the blood. They become overwhelmed and try to draw extra water out of the blood to dilute the glucose. This keeps your bladder full and it keeps you running to the bathroom.

Unquenchable Thirst:
If it feels like you can't get enough water and you're drinking much more than usual, it could be a sign of diabetes, especially if it seems to go hand in hand with frequent urination. If your body is pulling extra water out of your blood and you're running to the bathroom more, you will become dehydrated and feel the need to drink more to replace the water that you are losing.

Losing Weight Without Trying:

This symptom is more noticeable with Type 1 diabetes. In Type 1, the pancreas stops making insulin, possibly due to a viral attack on pancreas cells or because an autoimmune response makes the body attack the insulin producing cells. The body desperately looks for an energy source because the cells aren't getting glucose. It starts to break down muscle tissue and fat for energy. Type 2 happens gradually with increasing insulin resistance so weight loss is not as noticeable.

Weakness and Fatigue:

It's that bad boy glucose again. Glucose from the food we eat travels into the bloodstream where insulin is supposed to help it transition into the cells of our body. The cells use it to produce the energy we need to live. When the insulin isn't there or if the cells don't react to it anymore, then the glucose stays outside the cells in the bloodstream. The cells become energy starved and you feel tired and run down.

Tingling or Numbness in Your Hands, Legs or Feet:

This symptom is called neuropathy. It occurs gradually over time as consistently high glucose in the blood damages the nervous system, particularly in the extremities. Type 2 diabetes is a gradual onset, and people are often not aware that they have it. Therefore, blood sugar might have been high for more than a few years before a diagnosis is made. Nerve damage can creep up without our knowledge. Neuropathy can very often improve when tighter blood glucose control is achieved.

Other Signs and Symptoms That Can Occur:

Blurred vision, skin that is dry or itchy, frequent infections or cuts and bruises that take a long time to heal are also signs that something is amiss. Again, when these signs are associated with diabetes, they are the result of high glucose levels in the body. If you notice any of the above signs, schedule an appointment with your doctor. He or she will be able to tell you if you have reason to be concerned about a diagnosis of diabetes.

~By Debra Manzella, R.N.,

Thursday, August 20, 2009

Critical Limb Ischemia - Potential Solution and Treatment?

Medical Quarterly
Metro Magazine
August 2009
Duke Testing New Stem Cell Therapy
By Rick Smith

The name is not commonly known and is difficult to pronounce, but the disease afflicts an estimated 12 million Americans. It’s called critical limb ischemia. Treatments are lacking and often require amputation, but help may be on the way: A potential solution for people afflicted with diabetes and obesity who are facing amputation of a limb due to circulatory problems caused by ischemia is soon to begin clinical testing at Duke Uni versity.
The disease causes narrowing and hardening of arteries, thus reducing blood flow. If not treated, victims can suffer nerve and tissue damage. The disease can also trigger gangrene, which often requires amputation.
In lab tests on animals, the use of stem cells not only improved blood flow, but also grew new blood vessels. Dr. Chris Kontos, co-director of the Duke Heart and Vascular Group, will be coordinating the trial that focuses on the stem cell regime developed by Pluristem Thera peutics.
But these are not embryonic stem cells, which have created so much controversy within the medical community. Rather, Pluristem, an Israeli biotherapeutics company whose stock is traded on the Nasdaq, is pioneering the use of stem cells derived from the placenta.
“There is no good medical therapy for critical ischemia,” said Dr. William Prather, who is a consultant with Pluri stem and helped pick Duke as one of the sites for the test. “There are surgical therapies that can clean out the vessels, but there is no medication or procedure to grow new blood vessels around the obstruction. That is what we have proved in animals.”
Duke is currently enrolling subjects for the trials for the Phase I tests of Pluristem’s PLX-PAD solution. A similar trial will take place in Alabama. “Both locations have used other companies’ cells in the past, so they are familiar with stem cell therapy,” Prather said.
Allogeneic Method
Pluristem is working on a variety of products that would enable stem cell transplants between unrelated donors and patients. The concept is called allogeneic, or “taken from different individuals.” The company wants to treat both severe ischemic and autoimmune disorders; it recently received funding support from the Israeli government.
The Pluristem method is not the first to use stem cells as a potential treatment for ischemia, Prather pointed out. How ever, the other choice is stem cells taken from bone marrow. Placenta cells are much more widely available, less expensive and don’t require donors to go through the surgical process to extract cells from the hip.
“We don’t have to do any of that with our cells,” Prather explained. “Our cells come off the shelf, they are one size fit all, they come from material that is thrown away, and outpatients can be injected in a process that takes 30 minutes. They are observed for six hours and then sent home.”
In late July, the first patient was injected with the proposed treatment in a clinical trial in Germany being run in parallel with the US tests. As many as 12 patients will be injected, with a mix of smokers, diabetics and obese subjects to be tested in the US.
Phase I trials focus on safety. If the treatment is found to be safe, Phase II trials would begin. The US Food and Drug Administration granted Pluristem approval for the Phase I trials earlier this year.
The treatment is intended for victims of “late stage” ischemia who have not responded to other treatments or surgery and face the prospect of amputation. People selected for the trial will already have a condition related to ischemia, such as an ulcer or nerve pain.
All test patients will receive one injection and half will receive a second, Prather said. There will be no placebos. Pluristem will track both safety and efficacy data over a three-month period following the injections. Although the primary “end point,” or goal of the Phase I trial, is safety, Prather said doctors also will be able to track whether the patients show improvement.
“In animal trials, we saw improvement in blood flow in about three weeks,” Prather explained. “I’m not sure we can equate that to three weeks in humans, though. We could get efficacy in blood flow within a month or two months of injection.”
Even if the treatment proves safe and ultimately is granted FDA approval for sale, Prather pointed out the healing process would not be a quick one. “If these cells are going to be effective, blood flow improvement will be a matter of weeks and months, not inject today and improve tomorrow,” he said. “It just takes time for a new blood vessel to grow.”
Duke and Pluristem agreed to partner on the trial after Pluristem came in contact with Dr. Brian Annex, a former physician at Duke. “He is a world-renowned leader in angiogenesis (the growth of new blood vessels),” Prather said. “He was in transition at the time when we talked last year, and he recommended that we work with Dr. Kontos. Annex later joined the Pluristem Scientific Advisory Board.
“We are very excited about the possibilities,” said Kontos, who hopes for the first patient injections to be made by the end of August.

Wednesday, August 12, 2009

Peripheral Vascular Disease

There has to be knowledge in order to bring awareness...

From Wikipedia, the free encyclopedia

Peripheral vascular disease (PVD), also known as peripheral artery disease (PAD) or peripheral artery occlusive disease (PAOD), includes all diseases caused by the obstruction of large arteries in the arms and legs. PVD can result from atherosclerosis, inflammatory processes leading to stenosis, an embolism or thrombus formation. It causes either acute or chronic ischemia (lack of blood supply), typically of the legs.

Friday, August 7, 2009

Shammi Kapoor speaks about his battle with the little-known disease

By: Hemal Ashar Date: 2009-08-06 Place: Mumbai

Celebrities are notorious for keeping their guard up, not letting the world see that their star (literally) has dimmed, that they are human after all. So former star Shammi Kapoor deserves a double yahoo for letting his defences down and giving the world a peek into his frailties.

The actor was at the Breach Candy hospital on Tuesday afternoon, along with a clutch of doctors to raise awareness about peripheral vascular disease. The relatively little known disease occurs when there is a blockage of blood flow from the artery to organs other than the heart.

In familiar territory

The SoBo hospital is familiar territory for the actor, (also a kidney patient) who takes regular dialysis at the hospital. Shammi is also a Chronic Obstructive Pulmonary Disorder (COPD) sufferer, where his lungs have been compromised. He arrived in a wheelchair; and ribbed the docs at the press conference, "Ah, you all are wearing ties today." He then asked in jest, "What do you want me to talk about? The last time I winked at a girl? Okay, okay, I will tell you about my experience with vascular disease."

Lost toes

The flamboyant Kapoor was afflicted with the disease last year. He said, "I lost a toe on each of my feet to vascular disease. I was saved from losing my limbs by timely medical treatment." He then revealed how he heard the doctors who were operating on him in the operation theatre. "I was given local anaesthesia, so I could hear the docs speaking: "Here I found it, hey milaa vein, oh artery.

The pain was so bad, I started shrieking, an anaesthetist clamped my mouth shut." He said gesticulating wildly to laughter by the docs. The docs admitted that Shammi started bleeding while the operation was on and his thigh had swelled to twice the size, underlining the gravity of this disease.

Finally, Shammi when urged to give a message to mark Vascular Awareness Day on August 6, told people to take timely medical help, with the same flourish he delivered lines like Chahe koi mujhe jungli kahe on screen.

Monday, August 3, 2009

What is peripheral vascular disease?

Peripheral artery disease (PAD) is a heart condition similar to that of coronary artery disease and carotid artery disease. In PAD, the fatty deposits build up in the inner linings of the artery walls. These blockages restrict the blood flow circulation, mainly in arteries leading to the kidneys, stomach, arms, legs and feet.
In its early stages, a common symptom is cramping, or fatigue in the legs and buttocks during activity. Such cramping subsides when the person stands still. This is called “intermittent claudication.” People with PAD often have fatty buildup in the arteries of the heart and brain. Because of this association, most people with PAD have a higher risk of death from heart attack and stroke.
There are two types of these circulation disorders:
Functional peripheral vascular diseases don’t have an organic cause. They don’t involve defects in blood vessels’ structure. They’re usually short-term effects related to “spasm” that may come and go. Raynaud’s disease is an example. It can be triggered by cold temperatures, emotional stress, working with vibrating machinery or smoking.
Organic peripheral vascular diseases are caused by structural changes in the blood vessels, such as inflammation and tissue damage. Peripheral artery disease is an example. It’s caused by fatty buildups in arteries that block normal blood flow.
How is peripheral artery disease diagnosed and treated?
Techniques used to diagnose PAD include a medical history, physical exam, ultrasound, X-ray angiography and magnetic resonance imaging angiography (MRA).
Most people with PAD can be treated with lifestyle changes, medications or both. Lifestyle changes to lower your risk include stopping smoking, diabetes control and blood pressure. Become physically active; eat a low-saturated-fat, low-cholesterol diet.
PAD may require drug treatment, too. Drugs include medicines to help improve walking distance, antiplatelet agents and cholesterol-lowering agents (statins).

Wednesday, July 29, 2009

Alternatives to Amputation

Amputation of an arm or leg should always be a last resort. That’s why Florence Davis of Hillside, NJ sought the help of a talented team of doctors at Newark Beth Israel Medical Center in an effort to save her leg.

For over a year, Davis struggled with a persistent foot wound that restricted blood circulation in her leg. The problem became so severe that doctors were considering amputating the leg. However, the vascular specialists at Beth Israel had other plans for their 81 year-old patient. Doctors applied a new ultra-cold catheter technique to open several blockages in the arteries—a technique that would save her leg without any surgery.

If you’ve ever sough medical advice for the treatment of a wound, you know that wound care can be a tricky ailment that can often spiral into other diseases due to complications and infections. Davis suffered from peripheral artery disease (PAD), but wasn’t aware that the condition could be life-threatening and seriously debilitating. If left untreated, people who exhibit symptoms of PAD are four to five times more likely to get a heart attack or stroke. The pain in Ms. Davis’ foot became so severe that she could barely walk. To make matters worse, she got a cut on her toe that refused to heal, so she turned to the Advanced Wound Care and Hyperbaric Institute at Newark Beth Israel Medical Center for help.

Doctors began aggressive wound treatment, but tests show that she had three blockages in the artery that runs from her hip to her toe. Circulation had to be restored, but Davis was not a candidate for the traditional vascular bypass surgery that transplants blood vessels from a healthy limb to replace blocked vessels. The wound care specialists at Beth Israel referred Davis to Madhu Salvaji, DO, one of a handful of New Jersey doctors who uses the Polarcath system to treat patients. This sophisticated form of treatment combines cold therapy and angioplasty (a procedure that involves using a balloon to open clogged arteries) to help prevent future blockages.

“Cooling the blood vessel down to -10 degrees Celsius as the balloon is inserted in the clogged artery, causes targeted cell death and alters the new cells that will replace them, greatly reducing the chances of a future blockage,” explained Dr. Salvaji. Altogether, Dr. Salvaji opened three blockages using a combination of cold catheter, stent placement and artherectomy, a delicate process of removing plaque from the artery walls.

“All I had to do was lie still,” said Mrs. Davis about the three minimally invasive procedures that were performed in stages. Within two weeks, the swelling in her foot disappeared, her toe was healed and she was back to her daily walking, shopping, and gardening.

For more information about advanced wound care or treatment for peripheral artery disease at Newark Beth Israel Medical Center, please call 1-888-SBHS-123.

Thursday, July 23, 2009

Peripheral Arterial Disease (PAD)

Peripheral Arterial Disease (PAD) is also known as atherosclerosis, poor circulation, or hardening of the arteries. PAD progresses over time at variable rates in each individual depending on the area of circulation effected and one's health and family history. The signs and symptoms of PAD may not arise until later in life. For many, the outward indications will not appear until the artery has narrowed by 60 percent or more.

One method the body uses to adapt to the narrowed arteries is the development of smaller peripheral arteries that allow blood flow around the narrowed area. This process is known as collateral circulation and may help explain why many can have PAD without feeling any symptoms.

When a piece of cholesterol, calcium or blood clot abruptly breaks from the lining of the artery or a narrowed artery blocks off completely, blood flow will be totally obstructed and the organ supplied by that artery will suffer damage. The organs in PAD most commonly affected and researched are the legs.

What happens if the disease worsens?

The severity of PAD depends on when it is detected and any pre-existing health factors; especially smoking, high cholesterol, heart disease or diabetes. In the later stages, leg circulation may be so poor that pain occurs in the toes and feet during periods of inactivity or rest. This is especially true at night. This is known as rest pain, which usually worsens when the legs are elevated and is often relieved by lowering the legs (due to the effects of gravity on the blood flow).

Critical Limb Ischemia

The most advanced stages of PAD can lead to Critical Limb Ischemia (CLI) . Here the legs and feet have such severe blockage that they do not receive the oxygen rich blood required for growth and repair of painful sores and even gangrene (dead tissue). This condition, if left untreated, may require amputation.

Wednesday, July 22, 2009

Workshop on Surgery cure for Peripheral Vascular Disease organised by Ruby Hall

(I-Newswire) - Workshop on Surgery cure for Peripheral Vascular Disease organised by
Ruby Hall
- Surgeries performed on five patients -
Pune, Tuesday 20th July 2009: In a bid to spread awareness about breakthrough treatments of Peripheral Vascular Disease ( PVD ), also known as Peripheral Arterial Disease, Ruby Hall had organised a day-long workshop recently.
The workshop, conducted under the supervision of Dr Bhagat Reddy from Georgia, USA. Dr Shirish ( M.S ) Hiremath, Dr Dhanesh Kamerkar and Dr Chandrashekhar Makhale actually performed Endo vascular procedures on five patients, who were suffering from PVD.
For cases of PAD, someone requiring surgery the newly developed device called the Frontrunner is now available which works in a similar way like an excavator, which bore through the mud and sludge causing the blockage. “It is like an angioplasty and a by-pass surgery performed on the leg,” says Dr Kamerkar.
Dr. Shirish ( M.S. ) Hiremath, Director, Ruby Hall Clinic said, “Lower limb PVD is a serious threat to the Indian population especially because of our susceptibility to Diabetes. Since people with diabetes frequently have high blood pressure and high cholesterol levels, it further accelerates the development of atherosclerosis. Given that PVD in diabetes is largely asymptomatic, patient education plays a key role in preventing major complications later. While 82,000 people have diabetes-related leg and foot amputations each year in India, timely treatment can significantly reduce this number”.

The new technique of surgery, prevalent in the West for a couple of years has now been brought to India to help patients who have a high risk of surgery. By the use of a Frontrunner, surgeons can avoid major cuts and incisions on the patient’s body and open up the blockage with just a puncture, as in conventional Coronary Angioplasty.
The workshop, which has already been held at major cities like Bengaluru, Hyderabad etc. aimed to instruct doctors about new tools and techniques that they can learn to deal effectively with the threat of PVD .
PVD, a widely prevalent, progressive atherosclerotic disease that carries a high risk of limb loss, stroke, and premature death, which can affect anyone. It occurs when the arteries ( blood vessels ) that supply blood to various parts of the body become narrow because of the buildup of fatty deposits on the inside walls of the blood vessels of the heart ( coronary artery disease ), brain ( cerebrovascular disease ) and kidney ( renal artery disease ). Because of this, people with PVD have a higher risk of heart attack, stroke or kidney failure.
Dr. Shirish ( M.S. ) Hiremath who has the largest volume of Angioplasties, explained how cardiologists have got involved in managing leg issues.” Basically the process of atherosclerosis ( aging of the arteries ) is same all over the body. Measures taken to avoid atherosclerosis help both “Heart and Health.” Also, with enormous expertise in Heart arteries, Dr. Shirish ( M.S. ) Hiremath, feels they are very adapt to performing leg Angioplasties.
The doctors warn that people with PVD, if not treated are likely to undergo amputation of the limbs. “If people have better tools available to them, the results in treating patients can improve drastically. Thus, the workshop is beneficial not just to doctors and a boon to patients suffering from PVD, but to the whole society at large,” acts Dr Kamerkar.
One of the patients, Suhas Patil, who got operated said, “ I was suffering from daibetes from a very long time but I was not aware of PVD. When the doctors informed me about it, I had lost all hopes. There are many such people like me who are not aware of such consequences Such kind of workshops should be organized on a regular basis to make people aware about the disease. I would like to thank all the doctors who helped me in understanding the effects of the disease and guided in the right direction.”

Tuesday, July 21, 2009

PAD | Are You at Risk for Peripheral Arterial Disease?

PAD | Are You at Risk for Peripheral Arterial Disease?
Tuesday, July 21, 2009

You walk a block, then clutch your leg with what feels like a charley horse. You stop, and the pain does too. The discomfort may be a warning of a common yet serious condition called peripheral arterial disease (PAD).
In PAD, the same fatty material that can clog heart arteries builds up in the arteries of the legs, blocking blood flow. The risk for death from heart attack or stroke is six to seven times greater in people with PAD is equivalent to the risk of someone who has had a heart attack or stroke. Without prompt treatment, one in four people with the condition will suffer a heart attack, stroke or amputation or die within five years.
PAD is most often recognized when it causes claudication and fatigue, cramps, tiredness or pain in the leg or buttock muscles that goes away when you stop walking. Less frequently, it can cause ulcers or slow-healing wounds on the feet or toes, or pain in the feet or toes that disturbs sleep. However, as many as half to two thirds of those with the condition have no symptoms.
As with coronary heart disease, key risk factors for PAD are having diabetes, smoking or having smoked, and being over age 50. “If you have no other risk factors, age alone will increase risk and yet risk rapidly increases even in younger people who smoke or have diabetes,” says Alan T. Hirsch, M.D., professor of epidemiology at the University of Minnesota School of Public Health in Minneapolis. “We want people to recognize that if you are over 50 and have any other risk factor, you have a one in four chance of having this disease.”
Also at risk are African Americans and anyone with chronic kidney disease, high blood pressure, high blood cholesterol or a personal or family history of vascular disease, heart attack or stroke. An estimated 8 to 12 million people in this country have PAD.
If you have risk factors, talk to your doctor, whether or not you have symptoms. The PAD Coalition, a consortium of health organizations and government agencies, recommends that those at risk get a quick, painless, accurate and inexpensive diagnostic test called an ABI (ankle-brachial index).
The good news: PAD is both preventable and is very treatable. “PAD is a common and serious disease, which merits immediate and lifelong attention,” says Dr. Hirsch. “Become informed and take actions to protect your health.” Arms for Legs While exercise is helpful for people with PAD, walking is a typical workout for sufferers but can also be painful. Diane Treat-Jacobson, R.N., Ph.D., assistant professor at the University of Minnesota in Minneapolis, has done studies on the effects of exercise on people with this disease.
She recently discovered that supervised training using aerobic arm exercise was as beneficial as treadmill walking in improving walking distance. Treat-Jacobson notes that while results are preliminary, arm exercise might be a pain-free option that can “help break the cycle of disability or enable patients to start exercising sooner after a surgical procedure.”
Remember that peripheral arterial disease is both preventable and very treatable, but it is a a common and serious disease which merits your attention if you have any of the symptoms addressed in this article.
It is up to you to become informed about this disease and take active action to protect your health.

Monday, July 20, 2009


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HEART TO HEART: Understanding PVD

HEART TO HEART: Understanding PVD
Monday, July 20th, 2009 02:52:00

STAND up. Feel the ground beneath you. Is it firm? Walk around and jump up and down. Go kick a ball. Now look at your feet. Look at them hard.
Why have I asked you to do this? What is my point?

For most people, this is not something that we think of consciously. The ability to stand and walk is what all of us learned to do months after birth. It is a natural part of our everyday life.
Unfortunately, the same cannot be said of Ibrahim (not his real name). He had his left leg amputated above the knee in March this year. His right leg followed two weeks ago. His life will never be the same again.

Ibrahim is a 60-year-old man with peripheral vascular disease (PVD). It is an occlusive arteriosclerotic disease affecting the arteries to his legs.

He also has diabetes, hypertension and high cholesterol.

Although he does not smoke, he has the other risk factors for severe PVD.

His problem started in the middle of last year. He complained of cramp-like feeling at the back of both calves when walking. The medical term for this symptom is intermittent claudication.

After a few weeks, he began to notice the walking distance it took for the claudication pain to come on was becoming less.

In late November, he noticed a small wound on the sole of his left foot. He had no recollection of how he sustained it. He had been having numbness in his feet for some time before that and he attributed it to his longstanding diabetes. When he sustained the wound to his foot, he had no knowledge of it till later.

Ibrahim has had diabetes, hypertension and high cholesterol for more than 10 years. He was not diligent in taking his medications or clinic follow-up appointments.

Instead, he resorted to traditional treatment to help heal the wound. By the middle of February, the wound had become worse. It was bigger and the whole foot was in pain even at rest.

When he eventually came to the hospital two weeks later, all his left toes were black and gangrenous. Infection had already spread to the bones of his foot. He had osteomyelitis.

He initially refused medical advice to have a below-knee amputation. He insisted on the medical team to perform a miracle to save his leg. Unfortunately, despite aggressive treatment with intravenous antibiotics and regular wound care, his leg could not be saved. As I am writing this, Ibrahim is recovering in the hospital from his second amputation. Sadly, his case is not isolated.

He is just 1 of about 10,000 diabetics whose legs are amputated in Malaysia every year, where 40 to 50 per cent of these cases are preventable.

Did you know that patients with PVD have a four-fold risk of death from heart attack and heart-related diseases, and a two to three times greater risk of stroke?

Diabetics are two to four times more likely to get PVD and for those who also smoke, the risk of having an amputation is 30 per cent in the next five years. With the rising number of diabetic patients, which currently stands at 14.9 per cent in Malaysia for those above 30 years of age, PVD is fast becoming an epidemic.

As a clinical condition, PVD is grossly neglected, vastly underdiagnosed and badly managed. As with Ibrahim
and thousands others, severe PVD leading to critical limb ischaemia (painful leg at rest, non-healing wounds and gangrene) is the first presentation to the doctor. Chances of a good recovery will be smaller at this stage.

For some, it may even be too late.

Ignorance is the main cause of the rising number of PVD cases worldwide. Perhaps we place too much concentration on the symptoms and signs of heart attack and stroke that we tend to neglect PVD, the third commonest manifestation of cardiovascular disease.

To halt the growth of this serious disease, drastic measures need to be instituted before the situation gets out of hand.

Early identification of patients at risk of PVD, aggressive risk factor modification and timely referral to the vascular surgeon in severe cases is vital.

If you are diabetic or at high risk of getting PVD, please consider the following:
● Watch your diet. It has to be low in sugar and fat.
● Take your medicines as prescribed. Follow the advice of your doctor.
● Stop smoking.
● Exercise regularly.
● Take care of your feet. Make sure they are clean and dry at all times, especially in the spaces between
the toes.
● If numbness develops on the soles of your feet, take appropriate measures to protect your feet from accidentally having a cut.
● If you have any of the PVD symptoms and signs (claudication or critical limb ischaemia), see a doctor straight away.

Once you see a doctor, he may order an ankle-brachial pressure index (ABPI) test. It is a measure of the fall in blood pressure in the arteries supplying the legs compared to the pressure in the arms. A reduced ABPI (less than 0.9) is consistent with PVD. Values of ABPI below 0.8 indicate moderate disease and below 0.5 severe disease.

These days, CT angiogram which is a non-invasive imaging test, is being used on a wider basis to visualise the extent of the disease. Based on this and the clinical picture, the vascular surgeon will advise on the best treatment from the available options which are:

● Conservative measures with medicines and life style modification only.
● Angioplasty, which is the opening up of narrowed arteries using special balloons inserted through the groin. This is the preferred option in certain cases especially in those at high risk of surgery.
● Bypass surgery using either the saphenous vein from the leg or an artificial graft to circumvent the blockage in the artery.

If you have any questions or comments, feel free to write to me at See you next Monday.

Sunday, July 19, 2009

Saving limbs with drug-eluting stents

July 16, 2009
Saving limbs with drug-eluting stents
Filed under: Uncategorized — reducedapmiami @ 1:55 pm

Attempts to explore deprecatory limb ischemia in peripheral arterial disorder (PAD) patients with unworthy of-the-knee angioplasty are still thwarted by restenosis (the re-narrowing of the artery at the situate of angioplasty or stenting), the extremity due to the fact that replay treatments and the continued progression of atherosclerotic complaint, leading to tissue death (gangrene) and amputation.

Interventional radiologists have been studying a potential solution - the use of drug-eluting stents - and have found that these types of stents lessened the rate of repeat procedures to open these small arteries, according to results presented at the Society of Interventional Radiology’s 34th Annual Scientific Meeting.

“This is encouraging news for PAD patients with critical limb ischemia. The smaller blood vessels below the knee are more difficult to treat due to their size (3 millimeters) and are more prone to reclog than larger vessels. The use of drug-eluting stents in the tiny infrapopliteal arteries of the leg may significantly impact their care,” said Dimitris Karnabatidis, M.D., assistant professor of interventional radiology at Patras University Hospital in Rion, Greece. “Drug-eluting (or drug-coated) stents have emerged as a potential solution to the limitations of endovascular treatment of PAD patients with critical limb ischemia,” he added. An interventional radiologist performs a balloon angioplasty to open a clogged blood vessel and then places a drug-eluting stent in that artery. The stent acts as scaffolding to hold the narrowed artery open. Drug-eluting stents slowly release a drug for several weeks to block cell proliferation or regrowth, thus inhibiting restenosis.

Researchers from a single center studied 103 patients in a double-arm prospective registry who had critical limb ischemia and who underwent infrapopliteal revascularization with angioplasty and placement of either a drug-eluting stent (with sirolimus, an immunosuppressant drug) or a bare-metal stent (without a drug coating). The patients had regular follow-ups up to three years, and researchers studied how they did by stent type. In the first group, 41 patients (75.6 percent diabetics) were treated with bare-metal stents, and in the second group 62 patients (87.1 percent diabetics) were treated with drug-eluting stents.

At three years, those patients with drug-eluting stents had “significantly higher patency” (length of time the blood vessels stayed open and moved blood flow efficiently); reduced restenosis of the vessels; and consequently less clinical recurrence requiring repeat angioplasty, said Karnabatidis. “In the drug-eluting stent group, an estimated 60 percent of the treated arteries remained open at three years. This is significantly longer than the bare-metal stent group, where the arteries remained open only approximately 10 percent at 3 years,” said Karnabatidis. “This corresponds to a more than 5 times increased risk of vessel reclogging when bare metal stents were used,” he added. “Because of the reduced vessel restenosis, repeat angioplasties were necessary in only 15 percent of the patients in the drug-eluting stent group versus almost 35 percent in the bare-metal stent group up to 3 years - this being the equivalent to an almost 2.5-fold risk of repeat procedures in the case of bare metal stents,” noted Karnabatidis. “These statistical results are based on three-year adjusted survival analysis after application of a Cox model for multivariable analysis,” he explained.

If a person has critical limb ischemia, it means he or she is at great risk for tissue death due to lack of blood flow, which carries oxygen and nutrients to the cells. The severely restricted blood flow results in severe pain in the feet or toes, even while resting, and sores and wounds that will not heal. Tissue death (gangrene) and amputation are imminent at this advanced stage of PAD, which is caused by atherosclerosis, the hardening and narrowing of the arteries over time due to the buildup of fatty deposits called plaque.

“Multicenter randomized trials are necessary to support these promising results and build on the level of clinical evidence supporting the integral value of infrapopliteal drug-eluting stents in critical limb ischemia treatment,” he added. In the United States, drug-eluting stents are FDA-approved for the coronary arteries but not for infrapopliteal arteries. In Europe, drug-eluting stents have CE Mark approval for below-the-knee use.

Thursday, July 16, 2009

Critical Limb Ischemia


Critical Limb Ischemia

Laura Bolton, PhD, FAPWCA

Dear Readers:
Critical limb ischemia (CLI), the most severe stage of peripheral arterial disease, affects 250,000 new patients annually in the United States with an estimated 40% requiring amputation within 12 months of a CLI episode, in addition to an annual mortality rate of more than 20%.1,2 Distal bypass surgery prompts healing of lower extremity ulcers associated with CLI if resulting arterial patency supports skin perfusion pressure of at least 35 mmHg.3 Surgical bypass of the occluded arterial segment improves3,4 and extends primary arterial patency, though there is insufficient evidence to support improved amputation rates or mortality compared to most other modalities.4 What options are available to the individual for whom bypass surgery is no longer feasible? This month’s Evidence Corner reviews two studies evaluating efficacy of modalities for treating CLI in patients without further vascular surgery options, as the search for an effective treatment of CLI continues.
Critical Limb Ischemia
Reference: Kavros SJ, Delis KT, Turner NS, et al. Improving limb salvage in critical ischemia with intermittent pneumatic compression: a controlled study with 18-month follow-up. J Vasc Surg. 2008;47(3):543–549.
Rationale: Intermittent pneumatic compression (IPC) is a noninvasive method of increasing arterial circulation and ameliorating intermittent claudication in patients with peripheral arterial disease (PAD).
Objective: Evaluate clinical efficacy of IPC in patients with chronic CLI, nonhealing foot ulcers, and minor toe or transmetatarsal amputation after further options for arterial revascularization had been exhausted.
Methods: This retrospective cohort study compared two similar groups, each consisting of 24 consecutive patients, for whom further surgical bypass was not an option, and were cared for in a multidisciplinary community clinic from 1998–2004. Resting ankle-to-brachial ratios of systolic blood pressure (ABI), sitting transcutaneous oximetry (TcPO2) duplex graft surveillance, and foot radiography confirmed vascular status. Both groups received weekly debridement and biologic dressings for tissue loss and nonhealing amputation wounds of the foot due to CLI. Intermittent pneumatic compression allocation was based solely on a patient’s willingness to use it. The IPC inflation pressure was 85 mmHg to 95 mmHg and was applied for 2 seconds with a 0.2-second rise, 3 cycles per minute, for three 2-hour daily sessions. Adherence was monitored closely. Healing outcomes were “favorable” if complete healing with limb salvage occurred during 18 months. Outcomes were considered “adverse” if nonhealing caused below-knee amputation during that time.
Results: Groups were comparable at baseline on all arterial and wound parameters; prior amputation and comorbid factors were assessed. Four patients (17%) in the control group and 14 IPC (58%) patients healed (P < 0.01). The likelihood of limb loss in the control group was 7 times that of IPC subjects who also increased in TcPO2 (P = 0.0038).
Authors’ Conclusions: When used within a protocol of standard wound care, IPC significantly improves clinical healing and below-knee amputation outcomes of patients with inoperable CLI. This research sets the stage for rigorous prospective, multicenter, randomized, controlled trials (RCTs) of IPC to establish its role in healing while clarifying its indications for use.
FGF-1 Gene Therapy Decreases Amputation Rates in Patients With CLI
Reference: Nikol S, Baumgartner I, Van Belle E, et al. Therapeutic angiogenesis with intramuscular NV1FGF improves amputation-free survival in patients with critical limb ischemia. Mol Ther. 2008;16(5):972–978.
Rationale: Although controversial, with its long-term effects under scrutiny, angiogenic growth factor therapy has been proposed for treatment of critical limb ischemia in end-stage PAD. Acidic fibroblast growth factor (FGF-1) is a potent mitogen for vascular endothelial cells, inducing blood vessel formation in vitro and in vivo. A plasmid-based gene transfer delivery system for FGF-1, NV1FGF with “Conditional Origin of Replication” (pCOR), reduces the potential for propagation in the host environment while sustaining local FGF-1 production permitting less frequent treatment.
Objective: A Phase 2b, double blind, randomized, placebo-controlled clinical trial investigated the efficacy and safety of intramuscular NV1FGF versus placebo in subjects with CLI at high risk of amputation.
Methods: A European multicenter trial screened 125 patients with CLI ineligible for revascularization as confirmed by a vascular surgeon. Each patient had at least 1 nonhealing ulcer, a TcPO2 £ 20 mmHg, ankle pressure
£ 70 mmHg, and toe pressure £ 50 mmHg. Patients were randomly assigned to receive 8 intramuscular injections of 2.5 mL NV1FGF in a 0.2 mg/mL solution (n = 59) or similar placebo injections (n = 56) on study days 1, 15, 30, and 45. Percent of patients with at least 1 ulcer completely healed at week 26 was the primary outcome. Secondary outcomes TcPO2, ABI, amputation, and death were evaluated at week 52.
Results: Among 107 subjects evaluated for healing, 19.4% of NV1FGF-treated and 14.3% of control patients healed during 26 weeks (P = 0.514; not significant). Likelihood of amputation or of major amputation was reduced in the NV1FGF group (P = 0.011), which also experienced improvement in time to death or major amputation. No other secondary outcomes were statistically significant. Adverse events were comparable in both groups, supporting the safety of NV1FGF.
Authors’ Conclusions: This was the first double blind, prospective RCT in patients ineligible for bypass surgery. Despite the fact that no improvement in wound healing was seen it showed the potential for NV1FGF to significantly reduce amputation risk, potentially lowering mortality rates in these high-risk patients.

Clinical Perspective
Both publications aim to improve the lot of patients with serious vascular impairment, using either biochemical or physical modalities. Plasmid gene transfer of NV1FGF administered once every 2–3 weeks for the first 7.5 weeks of care appears to save limbs, though its effect on ischemic ulcer healing remains uncertain. Other plasmid growth factors either lack healing and amputation effects5 or heal wounds without reducing amputation.6 The capacity to save limbs in high-risk patients for whom surgery is no longer an option is equally compelling for NV1FGF and IPC. Limb salvage plus the healing benefits of properly applied IPC are unprecedented, although it was a small retrospective study and was potentially biased by selection of IPC-willing patients. Larger prospective RCTs on patients with CLI, perhaps comparing IPC with and without NV1FGF, would seem necessary. As a physical modality, IPC may be compatible with gene or biochemical therapy. These studies open potential care options for patients with CLI who are faced with possible amputation.

1. Dormandy J, Heeck L, Vig S. The fate of patients with critical leg ischemia. Semin Vasc Surg. 1999;12(2):142–147.
2. Dormandy J, Mahir M, Ascady G, et al. Fate of the patient with chronic leg ischaemia: A review article. J Cardiovasc Surg. 1989;30(1):50–57.
3. Tsuji Y, Hiroto T, Kitano I, Tahara S, Sugiyama D. Importance of skin perfusion pressure in treatment of critical limb ischemia. WOUNDS. 2008;20(4):95–100.
4. Fowkes F, Leng GC. Bypass surgery for chronic lower limb ischaemia. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD002000.
5. Powell RJ, Simons M, Mendelsohn FO, et al. Results of a double-blind, placebo-controlled study to assess the safety of intramuscular injection of hepatocyte growth factor plasmid to improve limb perfusion in patients with critical limb ischemia. Circulation. 2008;118(1):58–65.
6. Kusumanto YH, van Weel V, Mulder NH, et al. Treatment with intramuscular vascular endothelial growth factor gene compared with placebo for patients with diabetes mellitus and critical limb ischemia: a double-blind randomized trial. Hum Gene Ther. 2006;17(6):683–691.