OBJECTIVE -To prospectively determine risk factors for foot infection in a cohort of people with diabetes.RESEARCH DESIGN AND METHODS -We evaluated then followed 1,666 consecutive diabetic patients enrolled in a managed care-based outpatient clinic in a 2-year longitudinal outcomes study. At enrollment, patients underwent a standardized general medical examination and detailed foot assessment and were educated about proper foot care. They were then rescreened at scheduled intervals and also seen promptly if they developed any foot problem.RESULTS -During the evaluation period, 151 (9.1%) patients developed 199 foot infections, all but one involving a wound or penetrating injury. Most patients had infections involving only the soft tissue, but 19.9% had bone culture-proven osteomyelitis. For those who developed a foot infection, compared with those who did not, the risk of hospitalization was 55.7 times greater (95% CI 30.3-102.2; P Ͻ 0.001) and the risk of amputation was 154.5 times greater (58.5-468.5; P Ͻ 0.001). Foot wounds preceded all but one infection. Significant (P Ͻ 0.05) independent risk factors for foot infection from a multivariate analysis included wounds that penetrated to bone (odds ratio 6.7), wounds with a duration Ͼ30 days (4.7), recurrent wounds (2.4), wounds with a traumatic etiology (2.4), and presence of peripheral vascular disease (1.9).CONCLUSIONS -Foot infections occur relatively frequently in individuals with diabetes, almost always follow trauma, and dramatically increase the risk of hospitalization and amputation. Efforts to prevent infections should be targeted at people with traumatic foot wounds, especially those that are chronic, deep, recurrent, or associated with peripheral vascular disease.

OBJECTIVE—To report the incidence of diabetes-related lower-extremity complications in a cohort of patients enrolled in a diabetes disease management program. RESEARCH DESIGN AND METHODS—We evaluated screening results and clinical outcomes for the first 1,666 patients enrolled in a disease management program for a period of 24 months (50.3% men, aged 69.1 ± 11.1 years). RESULTS—The incidence of ulceration, infection, amputation, and lower-extremity bypass was 68.4, 36.5, 5.9, and 7.7 per 1,000 persons with diabetes per year. Amputation incidence was higher in Mexican Americans than in non-Hispanic whites (7.4/1,000 vs. 4.1/1,000; P = 0.003, odds ratio [OR] 1.8, 95% CI 1.2–2.7). The amputation-to-ulcer ratio was 8.7%. The incidence of Charcot arthropathy was 8.5/1,000 per year. Charcot was more common in non-Hispanic whites than in Mexican Americans (11.7/1,000 vs. 6.4/1,000; P = 0.0001, 1.8, 1.3–2.5). The prevalence of peripheral vascular disease was 13.5%, with no significant difference based on ethnicity (P = 0.3). There was not a significant difference in incidence of foot infection (P = 0.9), lower-extremity bypass (P = 0.3), or ulceration (P = 0.1) based on ethnicity. However, there were more failed bypasses in Mexican Americans (33%) than in non-Hispanic whites (7.1%). Mexican Americans were 3.8 times more likely to have a failed bypass (leading to an amputation) or be diagnosed as “nonbypassable” than non-Hispanic whites (75.0 vs. 44.0%; P = 0.01, 3.8, 1.2–11.8). CONCLUSIONS—The incidence of amputation is higher in Mexican Americans, despite rates of ulceration, infection, vascular disease, and lower-extremity bypass similar to those of non-Hispanic whites. There may be factors associated with failed or failure to bypass that mandate further investigation.

OBJECTIVE -To evaluate the effectiveness of dynamic plantar pressure assessment to determine patients at high risk for neuropathic ulceration. In choosing the cut point, we looked for an optimum combination of sensitivity and specificity of plantar pressure to screen for neuropathic ulceration.RESEARCH DESIGN AND METHODS -A total of 1,666 consecutive individuals with diabetes (50.3% male) presenting to a large urban managed care-based outpatient clinic were enrolled in this longitudinal 2-year outcome study. Patients received a standardized medical and musculoskeletal assessment at the time of enrollment, including evaluation in an onsite gait laboratory.RESULTS -Of the entire population, 263 patients (15.8%) either presented with or developed an ulcer during the 24-month follow-up period. As expected, baseline peak plantar pressure was significantly higher in the ulcerated group than in the group who did not ulcerate (95.5 Ϯ 26.4 vs. 85.1 Ϯ 27.3 N/cm 2 , P Ͻ 0.001). There was also a trend toward increased pressure with increasing numbers of foot deformities, as well as with increasing foot risk classification (P ϭ 0.0001). Peak pressure was not a suitable diagnostic tool by itself to identify high-risk patients. After eliminating patients without loss of protective sensation, using receiver operating characteristic (ROC) analysis, the optimal cut point, as determined by a balance of sensitivity and specificity, was 87.5 N/cm 2 , yielding a sensitivity of 63.5% and a specificity of 46.3%.CONCLUSIONS -The data from this evaluation continue to support the notion that elevated foot pressure is an important risk factor for foot complications. However, the ROC analysis suggests that foot pressure is a poor tool by itself to predict foot ulcers. Diabetes Care 26:1069 -1073, 2003N europathic foot ulcers in individuals with diabetes are precipitated by a combination of pressure and cycles of repetitive stress (1,2). Identification, quantification, and mitigation of pressure and cycles of stress (activity) are thought to be important components in risk assessment and management of patients both before and after ulceration (3-8).Several investigators have evaluated populations of high-risk patients to identify strata of foot pressures that might assist in assessment. Boulton et al. (9) reported that pressures were Ͼ110 N/cm 2 for every subject with a foot ulcer, suggesting a threshold pressure below which individuals would not ulcerate. Only 31% of individuals with diabetes without a history of ulceration demonstrated abnormal peak foot pressures based on the criteria of Boulton et al. However, it is not clear if a threshold pressure level exists because other reports have identified lower peak foot pressures at sites of neuropathic ulceration than those identified by . For instance, diabetic subjects with peak plantar pressures Ͼ65 N/cm 2 have been shown to be at a six times greater risk for ulceration than subjects with pressures below this value (3). In a previous case-control study, our group was unable to identify...

OBJECTIVE -It is reasonable to predict that diabetes-related lower-extremity amputations have a detrimental impact on quality of life. However, we are unaware of any study in the medical literature describing the functional level of diabetic patients with amputations. The objective of this study was to evaluate amputations among diabetic patients and to determine the functional level of these patients with the Sickness Impact Profile (SIP). RESEARCH DESIGN AND METHODS -We enrolled 124 patients with diabetes.Case subjects (n ϭ 35) were defined as patients who had undergone amputation of the lowerextremity, and control subjects (n ϭ 89) were defined as patients who had not undergone amputation. Study participants received a standard history and physical examination.RESULTS -Both the physical dimension scores (33.5 Ϯ 14.9 vs. 22.3 Ϯ 14.7, P Ͻ 0.001) and the total SIP scores (27.6 Ϯ 9.9 vs. 22.5 Ϯ 10.3, P ϭ 0.013) were significantly higher for amputees. However, the psychosocial dimension scores were not significantly different between case and control subjects (14.9 Ϯ 8.9 vs. 15.2 Ϯ 10.0, P Ͼ 0.05). Post hoc analysis showed that the group of patients who had undergone transtibial amputation had a significantly higher total impairment score than patients who had not undergone amputation (P ϭ 0.039). This is in contrast to patients with toe or midfoot amputations, for whom total impairment scores were not significantly higher than those for the control subjects. Interestingly, bilateral amputees did not have significantly higher scores on either SIP dimension compared with unilateral amputees.CONCLUSIONS -These findings exemplify the detrimental physical and psychosocial health status of patients with diabetes-related lower-extremity amputation.

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