The contribution of non-insulin-dependent diabetes to lower-extremity amputation in the community

BACKGROUND: Despite the significant public health burden of lower-extremity amputations in diabetes mellitus, few data are available on the epidemiology of lower-extremity amputations in diabetes mellitus in the community setting. METHODS: A retrospective incidence cohort study based in Rochester, Minn, was conducted. RESULTS: Among the 2015 diabetic individuals free of lower-extremity amputation at the diagnosis of diabetes mellitus, 57 individuals underwent 79 lower-extremity amputations (incidence, 375 per 100,000 person-years; 95% confidence interval, 297 to 467). Among the 1826 patients with non-insulin-dependent diabetes mellitus, 52 underwent 73 lower-extremity amputations, and the subsequent incidence of lower-extremity amputation among these residents was 388 per 100,000 person-years (95% confidence interval, 304 to 487). Of the 137 insulin-dependent diabetic patients, four subsequently underwent five lower-extremity amputations (incidence, 283 per 100,000 person-years; 95% confidence interval, 92 to 659). Twenty-five years after the diagnosis of diabetes mellitus, the cumulative risk of one lower-extremity amputation was 11.2% in insulin-dependent diabetes mellitus and 11.0% in non-insulin-dependent diabetes mellitus. When compared with lower-extremity amputation rates for Rochester residents without diabetes, patients with non-insulin-dependent diabetes mellitus were nearly 400 times more likely to undergo an initial transphalangeal amputation (rate ratio, 378.8) and had almost a 12-fold increased risk of a below-knee amputation (rate ratio, 11.8). In this community, more than 60% of lower-extremity amputations were attributable to non-insulin-dependent diabetes mellitus. CONCLUSIONS: These population-based data document the magnitude of the elevated risk of lower-extremity amputation among diabetic individuals. Efforts should be made to identify more precisely risk factors for amputation in diabetes and to intervene in the processes leading to amputation.     

Preventive foot care in people with diabetes

A number of effective, low-cost strategies are available to identify and treat the person at risk for diabetic foot ulcers and lower-extremity amputation. These strategies must be more widely adopted by all diabetic care providers to maintain the integrity and function of the lower limb, and thus improve the quality of life for people with diabetes.     

Risk of foot complications in long-term diabetic patients with and without ESRD: a preliminary study

OBJECTIVE: The purpose of this preliminary study was to generate hypotheses for future research about the relationship between ESRD and foot complications in patients with long-term diabetes. DESIGN: A cross-sectional prevalence study was conducted comparing a sample of long-term diabetic patients with ESRD to a sample of long-term diabetic patients without ESRD. SAMPLE/SETTING: A convenience sample of 132 patients with long-term diabetes (> 15 years), with (N = 60) and without (N = 72) ESRD, was selected from ambulatory care settings and dialysis units. METHODS: Data were collected by chart audit, structured interview, and physical examination. RESULTS: Foot complications were greater in individuals with diabetes and ESRD (25%) than in diabetic individuals without ESRD (10%) (p = 0.02). Neither neuropathy, past or current smoking, race, gender, nor age were significantly associated with current foot complications (either current infection, ulcer, gangrene, or amputation). CONCLUSIONS: Research is needed to better understand foot complications in persons with long-term diabetes and ESRD so that the effectiveness of nursing and medical interventions to stabilize or prevent foot complications can be evaluated.     

Prognostic value of the clinical examination of the diabetic foot ulcer

OBJECTIVE: To determine the value of the history, physical examination, and magnetic resonance imaging (MRI) in predicting successful primary healing of a foot ulcer in a diabetic patient. DESIGN: Prospective cohort study. SETTING: Durham (NC) Veterans Affairs Medical Center. PATIENTS: Sixty-four consecutive diabetic patients with 78 dermal ulcers through the full thickness of the skin and at or distal to the malleoli of the ankle. MEASUREMENTS AND MAIN RESULTS: A structured clinical history and physical examination were performed by two examiners, a physician participating in the study and the referring physician. Fifty of these patients with 63 ulcers underwent MRI. Patients were followed prospectively for 6 months after enrollment to ascertain healing of the ulcer, amputation, and death. During the 6-month follow-up period, 8 (13%) of the patients died. Seventeen (22%) of the ulcers were amputated, 17 (22%) of the ulcers failed to heal, and 36 (47%) healed primarily. Univariate predictors of healing at 6 months included age less than 65 years, diagnosis of diabetes within the last 15 years, painless ulcer, palpable ankle pulse, anklebrachial index greater than 0.5, and the physician's assessment of the overall likelihood of osteomyelitis. In a multivariable logistic regression model, predictors of healing included the presence of an audible pulse on Doppler examination (p = .01) and a painless ulcer (p = .04). The diagnosis of osteomyelitis on MRI did not predict healing in these patients. CONCLUSIONS: Foot ulcers in patients with diabetes frequently have poor outcomes; fewer than half the patients in this study healed their ulcers within 6 months. The vascular components of the clinical examination are the best predictors of healing in patients with a diabetic foot ulcer.     

Diabetic foot ulcers: prevention, diagnosis and classification

Diabetic ulcers are the most common foot injuries leading to lower extremity amputation. Family physicians have a pivotal role in the prevention or early diagnosis of diabetic foot complications. Management of the diabetic foot requires a thorough knowledge of the major risk factors for amputation, frequent routine evaluation and meticulous preventive maintenance. The most common risk factors for ulcer formation include diabetic neuropathy, structural foot deformity and peripheral arterial occlusive disease. A careful physical examination, buttressed by monofilament testing for neuropathy and noninvasive testing for arterial insufficiency, can identify patients at risk for foot ulcers and appropriately classify patients who already have ulcers or other diabetic foot complications. Patient education regarding foot hygiene, nail care and proper footwear is crucial to reducing the risk of an injury that can lead to ulcer formation. Adherence to a systematic regimen of diagnosis and classification can improve communication between family physicians and diabetes subspecialists and facilitate appropriate treatment of complications. This team approach may ultimately lead to a reduction in lower extremity amputations related to diabetes.     

The diabetic foot. Optimal prevention and treatment can halve the risk of amputation

Almost half of all lower leg amputations are performed in patients with diabetes. In over 70 per cent of these cases, amputation is precipitated by progression of foot ulceration to deep gangrenous infection. Most foot ulcers are preceded by trauma, usually due to ill-fitting shoes, and are precipitated by sensory motor neuropathy with varying degrees of peripheral vascular disease. The Swedish Medical Research Council and the Swedish Institute for Health Services Development arranged a conference on diabetic foot problems in April 1998, the purpose of which was to arrive at a consensus regarding the prevention and management of diabetic foot. It was concluded that a satisfactory multidisciplinary approach should include regular control of feet and footwear, preventive foot care (education, footwear, chiropody), continuous follow-up of high-risk feet, and early recognition of revascularisation. Continuous registration of amputation, irrespective of type, cause and site, might substantially reduce the amputation rate among diabetics. Were such an approach to reduce the incidence of diabetes-related amputation by 50 per cent, annual costs for the management of diabetic foot in Sweden would be reduce by SEK 400 million (the value of improved quality of life not taken into consideration).     

Air bubbles in the subclavian or internal jugular veins: a common finding on contrast-enhanced CT

BACKGROUND: Foot complications in diabetes incur huge human and medical costs. There is a high incidence of complicated diabetes mellitus in Far North Queensland, particularly in the indigenous communities. METHODS: An audit of 51 patients admitted to Cairns Base Hospital from July 1992 to December 1994 with diabetic foot complications requiring surgical intervention was performed. RESULTS: The majority of surgical procedures were for serious infections in neuropathic feet precipitated by minor trauma. Surgical procedures included debridement/drainage, minor amputation, major amputation and arterial bypass. Half of the patients required more than one procedure and/or multiple admissions. Average length of stay was 48 days. Indigenous patients were overrepresented in this audited group. CONCLUSIONS: Prevention or minimization of diabetic foot complications can be achieved only through improvement in education and vigilance at all levels of the treatment process from community to hospital. Special attention to the needs of indigenous communities with a high incidence of diabetes must be a feature of any future initiatives.     

Transmetatarsal amputation

We have reviewed the records of 25 patients who underwent a transmetatarsal amputation at San Francisco General Hospital. The average patient age was 63 years old. Twelve of the patients were diabetic, while transmetatarsal amputations were performed in eleven with simple arteriosclerosis. Two patients underwent amputations for either trauma or nonhealing ulcer. Thirteen of the patients healed their amputation, and twelve of these became ambulatory. Eleven required higher amputation, because of nonhealing due to infection in seven and progressive ischemia in four. One patient died on the first postoperative day of pneumonia. The failure group was younger, contained more diabetics, and had a higher incidence of infection. The operative procedure of transmetatarsal amputation is described. We believe that patients with distal gangrene without spreading infection should be considered for transmetatarsal amputation, reserving initial below-knee amputation for those with greater involvement of the foot.     

Clinical and radiographic findings that lead to intervention in diabetic patients with foot ulcers. A nationwide survey of primary care physicians

OBJECTIVE: To determine which elements of clinical history, physical examination, and diagnostic tests are important to primary care physicians in their management of foot ulcers in diabetic patients. RESEARCH DESIGN AND METHODS: We conducted a national mail survey of 600 primary care physicians to determine which patient characteristics and diagnostic test results were important in their decisions to seek radiographic studies, surgical referrals, and hospitalization for diabetic patients with foot ulcers. RESULTS: The case characteristics most likely to influence physicians to order advanced diagnostic or therapeutic interventions are the presence of osteomyelitis on plain radiographs, the failure of the ulcer to improve with conservative therapy, and the presence of visible bone, crepitus, or necrosis within the ulcer (P < 0.001). Information from the initial clinical history was less likely to influence physicians to order advanced diagnostic or therapeutic interventions (P < 0.001) than was information from the physical examination. CONCLUSIONS: We conclude that 1) the patient's history is relatively unimportant to primary care physicians in their management of diabetic foot ulcers; 2) the failure of conservative management is a major reason that primary care physicians order surgical referral, hospitalization, or radiographic testing for diabetic patients with foot ulcers; and 3) primary care physicians rely heavily on plain X ray of the foot, a test with poor sensitivity and specificity, in deciding whether to order further interventions for their diabetic patients with foot ulcers.     

The association between callus formation, high pressures and neuropathy in diabetic foot ulceration

The presence of an ulcer beneath callus on the diabetic foot has been a well-documented and common clinical finding. We have conducted a prospective study to examine whether callus can be used to predict plantar intrinsic neuropathic diabetic foot ulcer formation. Sixty-three diabetic patients (43 male, 25 Type 1), median age 62 years (IQ range 52, 67), median diabetes duration 17 years (IQ range 8,25) participated in the study. All had neuropathy and peak plantar foot pressures (measured using a dynamic optical pedobarograph) > or = 10 kg cm-2. Calluses and previous ulcers were documented and classified. All ulcers occurring prior to and during the study were recorded, re-examination was 15.4 (range 10-22) months from baseline. Seven ulcers (6 patients) occurred during the study. Pressures were higher in the ulcer than non-ulcer sub-group (p = 0.04) with a relative risk of developing an ulcer of 4.7 for an area of elevated plantar pressure. This compares with a relative risk of 11.0 for an ulcer developing under an area of callus, and a relative risk of 56.8 for an ulcer developing on a site of previous ulceration. This study confirms that a history of previous ulceration is the highest risk factor for ulceration and demonstrates, for the first time, that the presence of plantar callus is highly predictive of subsequent ulceration. Careful history taking and examination of the foot to detect the presence of callus require no special training or equipment and callus should be recognized as a 'high risk' factor for foot ulceration.     

The natural history of great toe amputations

The purpose of this study is to report the prevalence of reamputation following resection of the great toe and first ray in adults with diabetes. We abstracted the medical records of 90 diabetic great-toe and first-ray amputees admitted between 1981 and 1991. The most common etiologies of initial amputations were ulcer with soft tissue infection (39%), ulcer with osteomyelitis (32%), and puncture wounds (12%). Sixty percent of all patients had a second amputation, 21% had a third, and 7% had a fourth. Fifteen percent of the patients who had a second amputation had it contralaterally. Seventeen percent subsequently underwent a below-knee amputation and 11% had a Transmetatarsal amputation on the same extremity, 3% had a below-knee amputation, and 2% a transmetatarsal amputation contralaterally. The mean time from the first to the second amputation was approximately 10 months. The results of this study suggest that a large proportion of patients undergoing an amputation at the level of the great toe or first ray have subsequent amputations in the first year following the initial procedure. Additionally, it appears that the contralateral foot may be at significant risk for distal amputation following resection of the hallux or first day.     

The role of the pedunculopontine tegmental nucleus in relation to conditioned motor performance in the cat. II. Effects of reversible inactivation by intracerebral microinjections

OBJECTIVE: To describe lower-extremity functioning in community-dwelling older Mexican Americans and to examine its relationship with medical problems. DESIGN: Cross-sectional analyses of survey and performance-based data obtained in a population-based study employing area probability sampling. SETTING: Households within selected census tracts of five Southwestern states: Arizona, California, Colorado, New Mexico, and Texas. PARTICIPANTS: A total of 2873 Mexican Americans aged 65 years and older. MEASUREMENTS: A multidimensional questionnaire assessing demographic, sociocultural, and health variables. Standardized tests of lower-extremity physical functioning included measures of standing balance, repeated chair stands, walking, and an overall summary measure. RESULTS: Regression analyses revealed that being more than age 75 and female, having arthritis diabetes, visual impairments, or being obese or underweight were all significantly associated with performance on both individual and summary tests of lower-extremity functioning. In separate regression analyses, the total number of medical conditions was also associated with performance. CONCLUSIONS: The likelihood of predicting performance or inability to complete tests of lower-extremity functioning was greatest for those aged 80 and older, those with arthritis or diabetes, and those with three or more medical conditions. Because of the high prevalence of diabetes in Mexican Americans, documentation of the association of diabetes with performance-based tests of lower-extremity functioning may help guide early interventions targeted to prevent progression to more severe limitations or disability.     

Management of the diabetic patient: causes of leg ulceration

The diabetic patient is at risk of developing numerous complications, including foot ulceration. The ulcer may contain a neuropathic and ischaemic element. Regular preventive checks can assist in early detection of foot problems. Failing eye sight and absence of sensation often result in patients relying on the healthcare professional detecting abnormalities on their behalf. The long-term effects of foot ulceration in the diabetic patient are immobility, septicaemia and amputation. Treatment options exist for the neuropathic and ischaemic foot but they vary in complexity. Accurate assessment and early recognition of the clinical signs of neuropathy and ischaemic ulceration will ensure early detection and optimum treatment interventions for the diabetic patient.     

Screening to prevent renal failure in insulin dependent diabetic patients: an economic evaluation

OBJECTIVE: To examine the conditions necessary to make screening for microalbuminuria in patients with insulin dependent diabetes mellitus cost effective. DESIGN: This economic evaluation compared two strategies designed to prevent the development of end stage renal disease in patients with insulin dependent diabetes with disease for five years. Strategy A, screening for microalbuminuria as currently recommended, was compared with strategy B, a protocol in which patients were screened for hypertension and macroproteinuria. INTERVENTION: Patients identified in both strategies were treated with an angiotensin converting enzyme inhibitor. SETTING: Computer simulation. MAIN OUTCOME MEASURES: Strategy costs and quality adjusted life years (QALYs). RESULTS: The model predicted that strategy A would produce an additional 0.00967 QALYs at a present value cost of $261.53 (1990 US$) per patient (or an incremental cost/QALY of $27,041.69) over strategy B. The incremental cost/QALY for strategy A over B was sensitive to several variables. If the positive predictive value of screening for microalbuminuria (impact of false label and unnecessary treatment) is < 0.72, the effect of treatment to delay progression from microalbuminuria to macroproteinuria is < 1.6 years, the cumulative incidence of diabetic nephropathy falls to < 20%, or > 64% of patients demonstrate hypertension at the onset of microalbuminuria, then the incremental costs/QALY will exceed $75,000. CONCLUSION: Whether microalbuminuria surveillance in this population is cost effective requires more information. Being aware of the costs, recommendation pitfalls, and gaps in our knowledge should help focus our efforts to provide cost effective care to this population.     

Clinical and economic impact of implementing a comprehensive diabetes management program in managed care

Diabetes mellitus places a significant burden on the U.S. healthcare system. Because of the potential to reduce diabetic complications and costs through intensive management, diabetes has become a primary target for disease management programs. We performed a retrospective analysis of short-term baseline and follow-up clinical, economic, and member and provider satisfaction data from approximately 7,000 people with diabetes being treated through seven managed care plans using Diabetes Treatment Centers of America's Diabetes NetCare, (Nashville, TN), a comprehensive diabetes management program. Our analysis indicates that Diabetes NetCare achieved gross economic adjusted savings of $50 per diabetic member per month (12.3%), with gross unadjusted savings of $44 (10.9%) per diabetic member per month. Hospital admissions per 1,000 diabetic member years decreased by 18%, and bed days fell by 21%. Patients with diabetes were more likely to get HbAlc tests, foot exams, eye exams, and cholesterol screenings while enrolled in the program. These data suggest that implementation of a comprehensive healthcare management program for people with diabetes can lead to substantial improvements in costs and clinical outcomes in the short-term. It is expected that improvements will increase over time, with continuing improvements in health status and a reduction in the number of future diabetic complications.     

An estimate of the cost of in vitro fertilization services in the United States in 1995

OBJECTIVE: To estimate the cost of adding IVF treatment to a standard health care benefits package. In vitro fertilization cost is defined as the average charge for a single cycle of treatment in an existing IVF program. DESIGN: Cost analysis. SETTING: Two hundred sixty IVF centers active in the United States in 1993. MAIN OUTCOME MEASURES: In vitro fertilization utilization and outcomes for 1993 were estimated from data in an existing registry. In vitro fertilization charges were determined from a 1993 survey of IVF clinics. The resulting expenditures for benefits and premiums were projected to 1995 together with the additional cost if utilization were to increase by 300% or 500%. RESULTS: In the United States in 1993 there were 31,718 IVF cycles for which the average charge was $6,233, leading to a total expenditure of approximately $197.70 million for IVF services in 1993. The projected cost of adding IVF services to a typical employer health plan in 1995 would be $2.79 per annum and the premium would be $3.14. Benefits and premium costs for a 300% utilization increase were $8.37 and $9.41, respectively, and for a 500% increase, $13.95 and $15.69, respectively. CONCLUSIONS: The cost of IVF services would be a minute fraction of the annual cost of a typical family benefits program ($3,393). Savings from reduced utilization of alternative treatments would offset a portion of this increase. Increases in utilization rates should be controlled by clinical criteria.     

Health impact of peptic ulcer in the United States

OBJECTIVES: To assess the general outcome and impact of current and previous peptic ulcer disease on health status in the United States. METHODS: During the National Health Interview Survey of 1989, a special questionnaire on digestive diseases was administered to 41,457 randomly selected individuals. Various measures of impaired health in ulcer patients were expressed by their age- and sex-standardized prevalence rates. RESULTS: Ten to 15% of all subjects with a recent ulcer reported that they had been in poor health, incapable of major activity, or unable to work for some time during the 12 months preceding the interview. Twenty to 25% of the subjects with recent ulcers complained about restricted activity and had spent 7 or more days per year in bed. About 40% of all ulcer subjects had seen a physician five or more times within 12 months before the interview. These percentages were significantly lower in patients with previous ulcer histories but no active ulcer within 12 months, but they were still significantly higher than in subjects with no ulcer history at all. In the United States, expenditures attributed to recent ulcers amounted to $5.65 billion per year. CONCLUSIONS: In the United States, peptic ulcer disease is associated with major morbidity. Ulcer cure would result in large economic and medical savings.     

Involvement of heparin affin regulatory peptide in human prostate cancer

BACKGROUND: Compliance with hepatitis B virus (HBV) vaccine remains suboptimal, despite a recommendation by the Advisory Committee on Immunization Practices of the US Public Health Service that all newborns be vaccinated. Although a combined HBV-Haemophilus influenzae type b (Hib) vaccine may improve acceptance of the HBV vaccine, the clinical and economic consequences of this intervention are uncertain. OBJECTIVES: To compare the health impact and cost-effectiveness of the following 2 immunization strategies: current practice of administering HBV vaccine separately (75% compliance) and Hib vaccine alone or as part of a multivalent vaccine (95% compliance); and strategy of delivering a combined HBV-Hib vaccine (95% compliance). DESIGN: A Markov model simulated the natural history of acute and chronic HBV and Hib disease in a cohort of US newborns. Clinical and economic variables were obtained from published reports. RESULTS: The Hib-related outcomes were the same in both strategies, because the efficacy and compliance with Hib vaccine were assumed to be equivalent in both. A 53% reduction in the number of cases of HBV infection with the combination strategy (n = 8541) was estimated when compared with current practice (n = 18 044), along with 205 fewer HBV-related deaths per 1 million infants. Immunization costs of the combination strategy were $11.5 million higher than for current practice ($108.4 million compared with $96.9 million), whereas the cost of HBV-related disease was $4.0 million lower than in current practice. The incremental cost-effectiveness ratio for the combination strategy was $17700 per year of life saved. CONCLUSION: An HBV-Hib vaccine in US infants yields substantial benefits, with a cost-effectiveness ratio that is lower than that of many commonly used medical interventions.