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Global lessons improve amputation prevention

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Interdisciplinary foot screening and limb salvage programs in this country and around the world have successfully reduced diabetic foot ulceration and amputation rates, and in doing so have inspired others to initiate similar prevention programs in their own countries.

By Emily Delzell

Amputation risk in patients with diabetes has always been a global challenge. Increasingly, amputation prevention efforts are also going global, as practitioners from both developed and developing nations learn from each other’s successes.

The human and economic costs of diabetes-related lower extremity amputations are high. The mortality rate—about 50% five years after amputation—exceeds that of many cancers and experts estimate that in 2007 U.S. expenditures for foot ulceration and amputations were more than $30 billion.1

The global view, which reveals more than 1 million annual limb amputations—one every 30 seconds—is even more troubling, particularly since the International Diabetes Federation (IDF) predicts that current global prevalence of diabetes will burgeon from 285 million to reach 435 million by 2030.2 In the U.S., the burden of diabetes is expected to double from its current prevalence—25.8 million adults and children, or 8.3% of the population—by 2030.3

In the most developed nations the annual incidence of foot ulceration, which precedes amputation in 85% of cases, is about 2%. In poorer, developing nations a lack of access to care places about half of all persons with diabetes at risk for foot ulceration, and diabetes-related amputations are very common.4 Yet, the vast majority of amputations both in the U.S. and abroad are preventable. The World Health Organization and the IDF estimate that up to 85% of diabetes-related lower extremity limb amputations could be avoided with appropriate preventive and specialist care.5,6

For many years the bulk of amputation prevention research was conducted outside the U.S. That trend is changing, however, and a number of studies analyzing outcomes from U.S. programs have entered the literature.1,7,8 And, since 2002, experts from all over the world have been gathering at the Diabetic Foot Global Conference (DFCon) in Los Angeles to share information about programs and strategies that help prevent amputations. More than 900 diabetic foot specialists attended the 2011 conference to hear speakers from 50 nations, and attendance rose for the third consecutive year.

“Amputation prevention is a relatively new subspecialty field with multiple paths of entry, such as podiatry, orthopedics, and others. There are no board certifications or entry requirements, so the field mostly contains those with an interest in the area,” said Lee C. Rogers, DPM, associate medical director of the Amputation Prevention Center at Valley Presbyterian Hospital in Los Angeles, chair of the American Diabetes Association Council on Foot Care, and a course director at this year’s DFCon.

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“The number of practitioners with interest and expertise in diabetes-related amputation prevention is growing, but supply can’t keep up with demand,” Rogers said.

Overcoming barriers to care

In many countries, the number of podiatrists is extremely low, noted Andrew Boulton, MD, professor of medicine at the University of Manchester, U.K., visiting professor in the University of Miami’s Diabetes Research Institute, and a recipient of DFCon’s annual award for Advocacy in the Prevention of Amputation in Diabetes.

“Relatively few nations—including the U.S., the U.K., South Africa, Australia, New Zealand, and Scandinavian countries—provide good access to podiatrists, who are key members in multidisciplinary diabetes care teams. In Greece there is only one podiatrist. Singapore has three,” Boulton said. “The situation with respect to specialist diabetic foot clinics is equally poor. China, for example, has only a handful of clinics for the 92 million adults estimated to have diabetes. Despite these deficiencies, some nations have made important strides in prevention.”

In the U.S., there are large numbers of specialists, but growing numbers of patients with diabetes are stressing these valuable resources and regional differences in access can result in significant variations in care, said David G. Armstrong, DPM, MD, PhD, professor of surgery and director at the Southern Arizona Limb Salvage Alliance at the University of Arizona College of Medicine in Tucson.

“One of the interesting things about speaking with practitioners from around the world, particularly those from less developed nations, is the strides they’ve been able to make in care with limited material and human resources,” said Armstrong, who is a DFCon cochair. “Certainly, there are lessons to be learned there.”

In Brazil, following a 1988 diabetes census that showed increasing rates of the condition, the Ministry of Health began a national program of diabetes education and control, which came to be known as the Diabetic Save the Foot Project. Boulton, who has been involved since the project’s inception, noted that there were major barriers to success, primarily the number of podiatrists in Brazil (which was zero) and a lack of specialist foot clinics.

The project began in the country’s capital, Brasília, and its aims included training health care professionals in foot examination techniques and diabetic foot care. Educators trained nurses in neuropathic, vascular, and biomechanical manifestations of diabetes; monofilament screening techniques; ulcer management; basic podiatry care (nails, debridement, hydration, callus removal); patient and family education; prevention; and the organization of a basic outpatient clinic, with an emphasis on teamwork. The foundation of training was a simple mandate: each clinic visit must include removal of the patient’s shoes.9

“If there is one message I would send practitioners everywhere in the world, it’s that each time they see a patient with diabetes they must remove that person’s shoes and socks and examine their feet. Those with risk factors should be given education on how to care for and preserve their feet,” said Boulton. “Another major factor of the success of the Brazil program was that health care professionals, policy makers, and payers all came together and agreed on a set of principles.”

Now there are more than 70 foot care clinics in Brazil. At the original Brasília center the rate of amputations decreased 77.8% between 1992 and 2000.9

In Saudi Arabia, another country with few podiatrists (only five in the nation and only two who are Saudis) efforts are underway to improve quality of care and decrease lower limb complications, said Hasan Ali Alzahrani, MD, a vascular surgeon and vice dean for clinical affairs at King Abdulaziz University (KAU) in Jeddah, which has recently established a scientific chair for diabetic foot research.

“One of our greatest barriers is the lack of a national registry for diabetes-related amputations. Such a registry is a prerequisite to national health plans. But we are carrying out educational campaigns and constructing diabetic care centers attached to hospitals. In addition, at KAU Hospital we have implemented a holistic approach to care that includes patient education, involvement of relatives in patient care, and lifestyle interventions combined with pharmacological therapy,” he said. “This approach has resulted in a reduction of incidence of foot ulceration to 0.5%.”

Alzahrani advises U.S. practitioners to consider involving family members in patient care, especially foot observation and care.

“This may be particularly helpful in populations of patients whose cultural background includes an emphasis on the extended family,” he said.

Access to coordinated, specialized care

One of the most valuable lessons arising from DFCon and other sources is the importance of patient access to a cohesive, multidisciplinary team, Rogers said.

“Preventing amputations requires multiple practitioners from various specialties, which makes the treatment of those with at-risk limbs complex,” he said. “In many cases, optimal care for diabetic foot problems requires coordinated care from a podiatrist, a vascular surgeon, an infectious disease specialist, and others. A number of recent international programs and guidelines have focused on this team concept.”

The introduction of a multidisciplinary foot team at a large district hospital in Ipswich, U.K., for example, decreased amputation rates dramatically. The program emphasized continual team communication with frontline health care staff with a goal of increasing awareness of the at-risk foot. An analysis of data collected over an 11-year period showed the incidence of total, major, and minor amputations per 100,000 people with diabetes fell 70% (53.2 to 16), 81.6% (41.4 to 6.7), and 21.1% (11.8 to 9.3), respectively.10

The authors noted that, along with other factors cited, yearly analysis of performance data drove changes in practice that contributed to the reductions in amputations. Similar programs at other U.K. centers have also produced significant reductions in amputations by emphasizing establishment of care pathways and protocols for managing diabetic foot problems with input from vascular and orthopedic surgeons, orthotists, diabetic chiropodists, and diabetologists.11,12

Other published reports have highlighted the benefits of better-organized diabetes foot care. In Lithuania the introduction of a multidisciplinary approach and four annual podiatry visits decreased recurrence of foot ulceration by 48%.13 In an Italian center, foot ulceration recurrence rates decreased 53% with the use of prescription off-loading footwear.14

“There also are successful U.S. models of care that have driven reductions in amputations,” Rogers said. “The major causes of diabetes-related amputation—gangrene, infection, and nonhealing wounds—are well understood. What’s not as widespread, though efforts such as those presented at DFCon and elsewhere are attempting to fill this gap, are appropriate recognition of those risk factors in individual patients and multistage limb salvage efforts.”

Rogers advocates the use of what he calls a “stairway to amputation” as a treatment model. The steps on the stair are described in ascending order as: diabetes, neuropathy, ulceration, vascular disease, infection, and amputation. Once Rogers and his colleagues identify the stair step corresponding to a particular patient’s status they are better able to prescribe interventions that prevent progression up the stairway and, in some cases, move patients to a lower, less risky step.

The Broadlawns experience

In some isolated U.S. medical settings similar models are significantly decreasing amputation rates. An analysis of an intensive amputation prevention program established in a county hospital setting at Broadlawns Medical Center in Des Moines, IA, found that in the two years following the program’s implementation the number of limb losses decreased 72% and the high-low amputation ratio, a marker for limb-salvage outcomes, decreased eightfold.1

The Broadlawns program focused on amputation prevention using a six-step protocol for those with lower extremity wounds (see table). The protocol involved: identification and management of infection; identification and management of ischemia; off-loading pressure, which was maintained throughout wound healing; debridement of wounds; promotion of granulation; and wound closure.

A 2011 analysis of trends in lower extremity amputations among persons with diabetes in the Veteran’s Health Administration found reductions of 33% and 36% in minor and major amputation rates, respectively, during the five-year study period (2000-2004). The biggest decreases were seen in above-the-knee amputations, which were reduced by 49%. The analysis, published in the May issue of Diabetes Care,7 involved the records of all patients with diabetes seen at Veterans Health Administration (VHA) clinics and also tracked amputations in this population paid for by Medicare. The study included between 400,000 and 800,000 patients each year; most were white men.

The authors noted that in the 1990s the VHA implemented a national program of foot risk screening and referral, primarily based in primary care settings. During the study period risk for lower extremity amputation decreased 28%. Medical records showed that in 1998, 95% of veterans had a visual examination; 84% had palpitation of pulses; and 78% underwent a sensory examination. In 2004, 83% of individuals had a monofilament examination and 85% of those with risk factors were referred to a foot specialist.

The authors concluded that their findings suggested that this universal program of foot screening, tracked through performance measures, contributed to decreases in lower extremity amputations.

“Both globally and in the U.S.,” Rogers said, “it’s been shown that coordinated care by an integrated team that includes podiatrists, vascular surgeons, infectious disease specialists, and others is the most important factor leading to better outcomes in amputation prevention.”

References

1. Rogers LC, Bevilacqua NJ. Organized programs to prevent lower-extremity amputations. J Am Podiatr Med Assoc 2010;100(2):101-104.

2. Latest diabetes figures paint grim global picture. IDF website. Available at: http://www.idf.org/latest-diabetes-figures-paint-grim-global-picture. Accessed June 6, 2011.

3. Diabetes Statistics. American Diabetes Association website. Available at: http://www.diabetes.org/diabetes-basics/diabetes-statistics/. Accessed June 6, 2011.

4. Boulton A. The diabetic foot: epidemiology, risk factors, and the status of care. Diabetes Voice 2005;50(SI):5-7.

5. World Diabetes Day: too many people are losing lower limbs unnecessarily to diabetes. World Health Organization website. Available at: http://www.who.int/mediacentre/news/releases/2005/pr61/en/index.html. Accessed June 6, 2011.

6. The diabetic foot: amputations are preventable. International Diabetes Federation website. Available at: http://www.idf.org/Position_statementsdiabetic_foot. Accessed June 6, 2011.

7. Tseng CL, Rajan M, Miller DR, et al. Trends in initial lower extremity amputation rates among veterans health administration health care users from 2000 to 2004. Diabetes Care 2011;34(5):1157-1163.

8. Driver VR, Madsen J, Goodman RA. Reducing amputation rates in patients with diabetes at a military medical center: the limb preservation service model. Diabetes Care 2005;28(2):248-253.

9. Pedrosa HC, Leme LAP, Novaes, et al. The diabetic foot in South America: progress with the Brazilian Save the Diabetic Foot Project. Int Diabet Monitor 2004;16(4):10-17.

10. Krishnan S, Nash F, Baker N, et al. Reduction in diabetic amputations over 11 years in a defined U.K. population. Diabetes Care 2008;31(1):99-101.

11. Canavan RJ, Unwin NC, Kelly WF, et al. Diabetes- and nondiabetes-related lower extremity amputation incidence before and after the introduction of better organized diabetes foot care. Diabetes Care 2008;31(3):459-463.

12. Thomson FJ, Veves A, Ashe H, et al. A team approach to diabetic foot care—the Manchester experience. The Foot 1991;1(2):75-82.

13. Dargis V, Pantelejeva O, Jonushaite A, et al. Benefits of a multidisciplinary approach in the management of recurrent diabetic foot ulceration in Lithuania: a prospective study. Diabetes Care 1999;22(9):1428-1431.

14. Uccioli L, Faglia E, Monicone G, et al. Manufactured shoes in the prevention of diabetic foot ulcers. Diabetes Care 1995;18(10):1376-1378.

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