Reference and Resource Materials

Prevention and Early Intervention for Diabetes Foot Problems: A Research Review

Research articles, most published since 1990, were identified and retrieved through computerized searches of the National Library of Medicine database (MEDLINE). This review is not meant to summarize the entire literature on the subject, but rather to present a condensation and consolidation of the major findings concerned with prevention of and early intervention for diabetes foot disease.

The Scope of the Problem

National Goals for Diabetes Foot Care

During their lifetime, 15 percent of people with diabetes will experience a foot ulcer and between 14 and 24 percent of those with a foot ulcer will require amputation (1). National Hospital Discharge Survey data for 1996 indicate that 86,000 people with diabetes underwent one or more lower-extremity amputations (2). Diabetes is the leading cause of amputation of the lower limbs. Yet it is clear that at least half of these amputations might be prevented through simple but effective foot care practices.

Healthy People 2010, the U.S. Department of Health and Human Services’ report (3) that specifies health objectives for the nation, calls for:

a) An increase in the proportion of people with diabetes aged 18 years and older who have at least an annual foot examination (baseline 55 percent, target 75 percent).

b) A decrease in foot ulcers due to diabetes (baseline and target figures are “developmental”).

c) A decrease in lower extremity amputations due to diabetes (baseline 11 per 1,000, target 5 per 1,000 per year). This objective is based on the estimate that at least 50 percent of the amputations that occur each year in people with diabetes can be prevented through screening for high risk patients and the provision of proper foot care.

Ethnic Groups At Higher Risk for Amputation

Analysis of a statewide California hospital discharge database indicated that in 1991, the age-adjusted incidence of diabetes-related lower extremity amputations per 10,000 people with diabetes was 95.3 in African Americans, 56.0 in non-Hispanic whites, and 44.4 in Hispanics. Amputations were 1.72 and 2.17 times more likely in African Americans compared with non-Hispanic whites and Hispanics, respectively. Hispanics had a higher proportion of amputations (82.7 percent) associated with diabetes as opposed to other causes of amputation, than did African Americans (61.6 percent) or non-Hispanic whites (56.8 percent) (4).

Age-adjusted amputation rates in south Texas in 1993 were 60.68 per 10,000 for non-Hispanic whites, 94.08 for Mexican Americans, and 146.59 for African Americans (5). The incidence of amputations for Pima Indians in Arizona was 24.1 per 1,000 person-years compared to 6.5 per 1,000 person-years for the overall U.S. population with diabetes (6). Increased awareness and identification of diabetes-related foot disease is especially important in these high-risk ethnic groups.

The President’s Initiative to Eliminate Racial and Ethnic Disparities in Health is focused on eliminating serious disparities in health access and outcomes experienced by racial and ethnic minority populations in six areas of health. Diabetes is one of the targeted areas. A near term goal for this initiative is to reduce lower extremity amputation rates among African Americans with diabetes by 40 percent (7).

Frequency of Foot Examinations

Foot examinations, both by people with diabetes and their health care providers, are critical preventive actions. In the 1989 National Health Interview Survey (NHIS), 52 percent of all people with diabetes stated that they checked their feet at least daily, but 22 percent stated that they never checked their feet. More self-exams were reported by insulin-treated individuals than those who did not use insulin (8).

Estimates of the frequency of provider-performed annual foot examinations vary. Data from the Centers for Disease Control’s Behavioral Risk Factor Surveillance System (BRFSS) indicate that 55 percent of adults with diabetes ages 18 years and older reported having at least an annual foot examination by a health care provider in 1998 (mean value from 39 states) (9). BRFSS data from 1995 to 1998 indicate that 86.3 percent of people with diabetes had seen a physician or other health care provider for diabetes care in the previous 12 months; 67.7 percent of adults with diabetes reported having had their feet examined in the previous 12 months (10). In an earlier nationwide survey, primary care physicians reported performing semi-annual foot examinations for 66 percent of patients with type 1 diabetes and for 52 percent of patients with type 2 diabetes (11).

Personal and Financial Costs

Diabetes foot disease is a major burden for both the individual and the health care system and may increase as the population ages. The total annual cost for the more than 86,000 amputations is over $1.1 billion dollars. This cost does not include surgeons’ fees, rehabilitation costs, prostheses, time lost from work, and disability payments (12). Regarding quality of life, a study of patients with diabetes showed that those with foot ulcers scored significantly lower than those without foot ulcers in all eight areas of a measure of physical and social function (13).

Foot disease is the most common complication of diabetes leading to hospitalization. In 1995, foot disease accounted for 6 percent of hospital discharges listing diabetes and lower extremity ulcers, and in 1995 the average hospital stay was 13.7 days. The average hospital reimbursement from Medicare for a lower-extremity amputation in 1992 was $10,969, and from private insurers it was $26,940. At the same time, rehabilitation was reimbursed at a rate of $7,000 to $21,000 (14).

Prevalence estimates for ulcers in diabetes patient populations vary. Fifteen percent of all patients with diabetes in a population-based study in southern Wisconsin experienced ulcers or sores on the foot or ankle. The prevalence increased with age, especially in patients who were aged 30 or under at diagnosis of diabetes (15). In a large staff-model health maintenance organization, the incidence, outcomes and costs of treatment for foot ulcers were studied over two years in a group of patients with diabetes. In this population, the incidence was nearly 2 percent per year and the direct medical care cost for a 40- to 65-year-old male with a new foot ulcer was $27,987 over the two years after diagnosis (16).

After an amputation, the chance of another amputation of the same extremity or of the opposite extremity within 5 years is as high as 50 percent. The 5-year mortality rate after lower extremity amputation ranges from 39 to 68 percent (8).
 

Causative Factors

Risk Factors for Lower Extremity Amputation (LEA)

Peripheral neuropathy, peripheral vascular disease, and prior foot ulcer are independently associated with risk of LEA (17, 18). A 1996 study of Pima Indians with diabetes confirmed this finding and included the presence of foot deformity as another independent risk factor (19). The presence of plantar callus also is highly predictive of subsequent ulceration in patients with diabetic neuropathy and is more predictive of ulceration than increased plantar foot pressures (20).

Hyperglycemia is an additional risk factor. In a 1996 study, Finnish researchers determined risk factors for amputation in 1,044 middle-aged patients with type 2 diabetes who were followed for up to 7 years. Because the incidence of amputation was similar in both sexes (5.6 percent men and 5.3 percent women), all statistical analyses were carried out combining men and women. This study found that high fasting plasma glucose levels at baseline, high HbA1c, and the duration of diabetes were independently associated with a two-fold risk of amputation. Signs of peripheral neuropathy, bilateral absence of vibration sense, and bilateral absence of Achilles tendon reflexes were two times more frequent in patients with amputation than in patients without amputation (21) .

The Diabetes Control and Complications Trial (DCCT), a ten-year clinical study that concluded in 1993, demonstrated that keeping blood glucose levels as close to normal as possible slows significantly the onset and progression of eye, kidney, and nerve diseases caused by diabetes. The study showed that any sustained lowering of the blood glucose helps, even if the person has a history of poor control (22). A follow-up study indicated that the reduction in risk for microvascular changes persisted for at least four years after the DCCT ended, despite increasing blood glucose levels (23). The United Kingdom Prospective Diabetes Study reported that type 2 patients randomized to intensive blood glucose control with sulfonylureas or insulin had a significantly lower pre valence of neuropathy at 9 and 15 years than patients randomized to conventional therapy (24).

Evidence for a relationship between use of tobacco and/or alcohol and ulcers or amputation is variable (14). Cigarette smoking, however, is a major risk factor for microvascular and macrovascular disease and is likely to contribute to diabetes foot disease (25). People with foot and ankle neuropathy are more likely to have gait abnormalities, postural instability, and sway, and are 15 times more likely to suffer some type of injury during ambulation than those without neuropathy (26, 27, 28, 29, 30).

The most important risk factors for diabetes foot problems, however, are peripheral neuropathy and peripheral vascular disease, as noted by Shaw and Boulton. There also is a complex interplay between these abnormalities and a considerable number of other contributory factors such as limited mobility, altered foot pressures, glycemic control, ethnic background, and more. The authors stress, however, that identification of patients at high risk for ulceration is simple and preventive care should focus on patient education (31).

Causal Pathways for Lower Extremity Amputations (LEA)

A study of the causal pathways for LEA in patients with diabetes identified the most common sequences of events. Seventy-three percent of the amputations in study subjects were a result of the causal sequence of minor trauma, cutaneous ulceration, and wound healing failure. Estimates of the cumulative proportions of various causes indicated that 86 percent of amputations were attributed to initial minor trauma causing tissue injury (32).

Precipitating or Pivotal Events

In the causal pathway study noted above, foot trauma was caused by shoe-related repetitive pressure leading to cutaneous ulceration in 36 percent of all cases, accidental cuts or wounds in 8 percent, thermal trauma (frostbite or burns) in 8 percent, and decubitus ulceration in 8 percent (32). Similarly, another study found that in one-third of diabetic amputees with peripheral arterial disease, the initial lesion was self-induced. The most common cause of self-injury was ill-fitting new shoes; the second most common cause was cutting toenails improperly (33). Other investigators identified external precipitating factors in 84 percent of study patients with foot ulcers. The most common factors were ill fitting shoes/socks, acute mechanical trauma, stress ulcer, and paronychia (34).
 

Identifying Patients at Risk

Tools to Identify High Risk Feet

The importance of identifying individuals at risk for foot ulceration and LEA and the need for preventive foot care practices for both the provider and the patient are significant (35). Identifying patients’ risk category for foot ulceration helps to determine the frequency needed for provider foot examinations, the level of emphasis on self-care of the feet, and patient responsibilities (36).

Several simple tools have been developed to identify people at high risk for ulceration. These tools include a patient report and a clinical examination to quantify loss of peripheral sensation (using a monofilament or vibration perception threshold testing), and to detect the presence of foot deformities, peripheral vascular disease, and prior foot ulcers (37, 38). The largest study to use the Semmes-Weinstein 5.07 (10-gram) monofilament is the Strong Heart Study of 3,638 American Indians living in Arizona, North and South Dakota, and Oklahoma (39). Use of these measures has been shown to predict subsequent ulceration and amputation (37).

In one study, during annual patient examinations, researchers recorded the presence of a foot deformity, history of lower extremity ulceration or amputation, and the ability to perceive the Semmes-Weinstein 5.07 (10-gram) monofilament at eight sites on the plantar surface of each foot. Based on the findings, subjects were classified as sensate or insensate and placed in one of four risk categories. Insensitivity to the monofilament occurred in 68 (19 percent) of the patients screened. Over a 32-month follow-up period, 41 of these patients developed ulcerations and 14 amputations occurred (37).

The recommended number of monofilament applications needed to assess the risk for ulceration varies. One study shows that an 8-site 5.07 (10-gram) monofilament examination (4 sites per foot) can be completed in 40 seconds and has 90 to 95 percent of the sensitivity of a 16-point examination. The four-site-per-foot examination specifies two of the touch sites – the first and third metatarsal heads. For the other two sites, the authors suggest any toes or other metatarsal heads. All sites should be free of calluses (40). Another study suggests that reasonable sensitivity and specificity (80 and 86 percent, respectively) to detect patients with an insensate foot can be achieved when the plantar aspect of either the first or fifth metatarsal head cannot feel a 5.07 (10-gram) monofilament (41).

A self-administered sensory test with a 5.07 (10 gram) monofilament may be useful to identify high risk feet. In a study that compared patient and provider sensory test findings for 145 subjects, 68 percent of patients self-tested without the assistance of another person, and patient/provider disagreement with findings occurred in 12 percent (18) of cases. Sensory loss, previously undetected by providers, was found in 16 percent (23) of patients. Self-administered tests provided patients an opportunity to become more active team members and resulted in early detection of insensate feet. The authors caution that self-testing should not replace regular foot evaluation by a health care provider (42).
 

Provider and Patient Education

Education Reduces Lower Extremity Abnormalities

In a randomized, controlled study, researchers provided intervention patients with foot care education, behavioral contracts, and telephone and postcard prompts. The researchers placed foot care prompts on the medical record, and provided practice guidelines and flow sheets to clinicians assigned to those patients. Results showed that primary care physicians in the intervention group conducted more examinations of lower extremities, identified those at risk for amputation, and referred more patients for specialized foot care. Patients in the intervention group received more patient education, made more changes in appropriate self-care behaviors, and had fewer short-term foot problems than patients in the control group (43).

Ollendorf et al. developed a model to estimate the economic benefits of amputation prevention strategies targeted at individuals with a history of foot ulcer over a period of three years. Estimates were based on an average lifetime cost of $48,152 for lower extremity amputation. For an estimated 679 individuals during the first year, the total potential economic benefits of strategies to reduce amputation risk ranged from 2–3 million dollars over three years ($2,900 to $4,442 per person with a history of foot ulcer). Benefits were highest for patient/provider educational interventions, followed by therapeutic shoe coverage, and multidisciplinary care (44).

Multidisciplinary team care can be a cost-effective method for foot screening, preventive care, and treatment of active ulcers (43, 45, 46). One study of team care for high risk patients with a history of foot ulcers found a 2-year foot ulcer incidence rate of 30 percent in the intervention group compared with 58 percent in the standard treatment group. The team involved physicians, nurses, podiatrists and shoe specialists (47).

A study of 639 patients in a rural primary care clinic showed significant reductions in lower extremity amputations. This prospective study of American Indians with diabetes, compared three consecutive 2- to 3-year time periods:

• a “standard care” period during which patients received foot care at the discretion of the primary care provider;
• a “public health” period during which patients were screened for foot problems and high risk individuals received foot care education and protective footwear;
• and a “stepped care” period during which comprehensive guidelines for foot management were adapted to their practice and implemented by a 6-person primary care team.

The average annual amputation incidence per 1,000 diabetic person-years was 29 in the first period, 21 in the second, and 15 in the third, an overall 48 percent reduction (48).

A study was conducted at six Veterans Affairs Medical Centers to determine how accurately and reproducibly primary care providers could carry out a screening examination (including use of a monofilament) for foot ulcer risk among patients with diabetes. Forty primary care providers (including non-physicians) examined 147 patients; 2 primary care providers examined each patient; and a foot care specialist also examined 88 patients. The results showed that the foot examination was reproducible among primary care providers and accurate when compared with a foot care specialist, except in the assessment of foot deformity and pedal pulses (49). When training providers to conduct foot exams, particular attention to these skills may be important.

Components of Effective Self-Management

Findings from several studies indicate effective components of patient education that contribute to successful patient outcomes. These include giving detailed foot care recommendations, requesting patient commitment to self-care, demonstrating and practicing foot care procedures, and communicating a persistent message that foot complications can be avoided by self-care. In comparing the effectiveness of intensive versus conventional education, researchers found that patients in the intensive group showed greater improvement in foot care knowledge, better compliance with the recommended foot care routine, improved satisfaction with foot care, and greater reduction in the number of foot problems requiring treatment (50, 51).

Foot care recommendations and demonstrations should include: washing, drying, and inspecting the feet; applying an emollient; cutting toenails; treating minor foot problems; selecting suitable footwear; dealing with temperature extremes; and contacting the physician if problems do not resolve quickly.

Lubricating the feet may be a simple yet very important way to help prevent foot ulcers. Over a one-year period, study patients who infrequently lubricated their feet were 3.1 times more likely to have a foot lesion than those who frequently lubricated their feet (52).

Patients with high risk feet should inspect them twice a day. Those with peripheral neuropathy, vascular disease, or eye disease should not attempt to cut their own toenails as this can lead to serious self-inflicted injury.

It is important for a health care provider or diabetes educator to review with the patient all written take-home instructions for self-care of the feet (36). In a program for African Americans, patients reported that the most useful parts of a take-home packet were the patient instruction booklet, the large hand mirror, and the foot care knowledge self-test with explanations of the answers (53).

Researchers found that the frequency of desired self-care behaviors improved when patients were given specific instructions stated as precisely as possible such as “dry between toes,” “file calluses,” and “never go bare foot” rather than more general instructions such as “avoid injury to your feet” (43). Patients should never be allowed to walk on open plantar ulcers since continuous application of mechanical load will prevent healing. Walking aids, footwear modifications, or other interventions must be used to relieve weight (54).

Step-by-step guidelines have been published to assist providers to conduct patient education workshops on foot care including how to attract participants, promote the workshop, develop the agenda, identify appropriate speakers, and conduct a post-workshop evaluation (55).
 

Clinical Issues

Provider Foot Care Practices

A documented annual comprehensive foot examination is included in a set of national quality improvement measures for diabetes care as part of the Diabetes Quality Improvement Project (DQIP) (56). Numerous public agencies (the Department of Defense, the Health Care Financing Administration (HCFA), the Indian Health Service, and the Veterans Health Administration) and private groups (the American Diabetes Association Provider Recognition Program and the National Committee for Quality Assurance) are using some or all of this set of eight DQIP performance measures. HCFA is responsible for Medicare and managed care plans that serve Medicare beneficiaries, as well as Medicaid programs. DQIP measures are likely to increase the frequency of documented annual foot exams by health care providers.

A study of provider practices found that clinicians were likely to prescribe preventive foot care behaviors when they were aware of a patient’s high risk for LEA as evidenced by prior history of foot ulcer. Clinician awareness of two other major risk factors (peripheral neuropathy or peripheral vascular disease), however, did not increase preventive care practices. The study’s authors concluded that physicians and patients need periodic reminders to identify patients in all high risk categories for ulcer or amputation and to schedule visits for foot care and education in self-care (17). To prevent unnecessary progression of foot problems, proactive communication is recommended between foot care specialists and providers less familiar with diabetes foot care management, as well as timely referral from primary care providers to specialists as necessary (1).

Self-care Limitations in the Elderly

Barriers to carrying out daily foot care noted by elderly study subjects included lack of motivation, forgetfulness, vision problems, joint and knee problems, and family responsibilities (53). The ability of elderly people to identify foot lesions was investigated further in a matched comparison, controlled study. Findings showed that 43 percent of patients with a history of foot ulcers could not reach and remove simulated lesions on their toes; over 50 percent of the older subjects reported difficulty trimming their toe nails; and only 14 percent had sufficient joint flexibility to allow inspection of the plantar aspect of the foot. It can be concluded that elderly people who are unable to perform daily self-care of the feet would benefit more from regular foot care given by others than from intensive education (57).

Exercise

In people with diabetes, regular exercise can lower blood glucose, improve insulin sensitivity, raise HDL cholesterol, improve blood flow and heart muscle strength, enhance fibrinolysis, control weight, increase muscle mass, and provide an overall sense of well being. Because of these effects, regular exercise may also delay the onset of neuropathy and atherosclerosis. People who have had type 1 diabetes for more than 10 years, or type 2 diabetes for more than 5 years, should be screened for medical risk prior to beginning an exercise program. While the presence of neuropathy does not rule out exercise, care should be taken not to worsen soft tissue and joint injury or cause foot ulcers or bone injury. Stretching muscles before exercise is important to prevent ligament strain. Swimming or bicycling are recommended forms of exercise because they avoid abrasion to the feet (58). Attention to the construction and fit of footwear is essential.
 

Special Footwear for the Insensate Foot

Repetitive Stress and Special Footwear

People with intact sensation respond to repetitive stress that occurs during walking either by shifting the pressure to another part of the foot, by modifying the way the foot meets the ground, by resting, or by checking their shoes for problems. With the loss of peripheral sensation, however, many people with diabetes have no indication of lower extremity pain, pressure, or trauma and do not take measures to modify repetitive pressures. Lack of feeling makes shoe-fitting assistance essential.

Properly-constructed and well-fitting shoes and shoe inserts can minimize localized stresses by redistributing forces during walking. Besides helping patients keep feet healthy, shoes and orthoses also can help prevent diabetes complications. Investigators in a recent study found that after healing of the initial ulcer, re-ulceration occurred after one year in 58 percent of patients who resumed wearing their own footwear, compared to 28 percent of those who wore therapeutic footwear (59).

Shoe color can contribute to thermal injury of the insensate foot when shoes are worn in the sun for a prolonged period (2 to 3 hours). One study showed that after 30 minutes of exposure to radiant heat, the mean increase in temperature was between 7.8 and 13.6 degrees Fahrenheit greater in a black leather walking shoe than in a similar white shoe (60).

Another study compared the prevalence and severity of foot deformities and the development of ulceration in people with diabetes after a great toe amputation. Due to altered pressure distribution, the foot with great toe amputation developed more frequent and more severe deformities of the lesser toes and metatarsophalangeal joints compared to the other intact foot. Because these patients were at high risk for subsequent ulceration, the use of special inserts and footwear to protect the feet was highly recommended (61).

Footwear and the Medicare Shoe Benefit

Professionally fitted shoes and prescription footwear are an important part of the overall treatment of the insensate foot because they aid in preventing limb loss. Footwear should relieve areas of excessive pressure, reduce shock and shear, and accommodate, stabilize, and support deformities. The type of footwear provided will depend on the patient’s foot structure, activity level, gait, and footwear preference (1).

Shoes should be long enough, and have room in the toe area and over the instep. Shoes with laces or Velcro allow adjustment for edema and deformities. Most people with early neuropathic changes can wear cushioned commercial footwear such as walking or athletic shoes. When used in conjunction with an off-the-shelf soft accommodative insole (plastazote/urethane viscoelastic), comfort shoes and athletic footwear were as effective as prescribed depth shoes in reducing certain metatarsal and great toe pressures (62). Some people, however, may need the pressure areas redistributed with custom orthotics that often require prescribed depth footwear.

Custom-molded shoes, depth shoes, inserts, and shoe modifications can be fitted and furnished by a podiatrist, orthopedic foot surgeon, orthotist, or pedorthist. Depth-inlay shoes provide more room for toe deformities and for the insertion of customized insoles. Extra-wide shoes provide more room for bunions and other abnormalities. Rocker sole shoes reduce pressure under metatarsal heads and toes. They are particularly useful for reducing the risk of ulceration in patients with a stiff and rigid first metatarsal joint (63).

Since 1993, the Medicare footwear benefit has made special footwear available to more patients than ever before. To obtain coverage, patients must have physician certification that they are at high risk for ulceration or amputation, receive a written footwear prescription from a podiatrist or other qualified physician, and obtain the footwear from a qualified provider or supplier who will then file the appropriate claim forms (64). Utilization of the Medicare benefit was low in 1995 for three states studied – Washington, Alaska, and Idaho. Altogether, less than one percent of beneficiaries with diabetes meeting the appropriate criteria for the footwear benefit had a therapeutic footwear claim (65). Clearly, there is an opportunity to increase awareness of the availability of this benefit and how to obtain reimbursement.
 

Conclusion

The staggering human and economic costs of diabetes foot disease may be reduced significantly with increased practice of several simple preventive care measures designed to prevent foot ulcers and lower extremity amputations. Routine annual foot exams to identify high risk feet facilitate early interventions to help reduce the incidence of the most common precipitating events including injury and footwear-related trauma to the insensitive foot. The key elements of preventive care include: annual examination of the feet by health care providers to determine risk factors for ulceration; subsequent examination of high risk feet at each patient visit; patient education about daily self-care of the feet; use of proper footwear; and careful glucose management. National recommendations and objectives support the application of these practices based on the strong and time-tested evidence for the prevention of lower extremity ulcers and amputations. These national objectives can serve as a galvanizing call to action for policy makers, health care providers, and people with diabetes to make diabetes foot care and prevention a high priority.

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