Outcomes deteriorated with increasing grade and stage of wounds when measured using the University of Texas Wound Classification System.

A prospective multicenter trial O R I G I N A L A R T I C L EOBJECTIVE -Diabetic foot ulceration is a preventable long-term complication of diabetes. A multicenter prospective follow-up study was conducted to determine which risk factors in foot screening have a high association with the development of foot ulceration.RESEARCH DESIGN AND METHODS -A total of 248 patients from 3 large diabetic foot centers were enrolled in a prospective study. Neuropathy symptom score, neuropathy disability score (NDS), vibration perception threshold (VPT), Semmes-Weinstein monofilaments (SWFs), joint mobility, peak plantar foot pressures, and vascular status were evaluated in all patients at the beginning of the study. Patients were followed-up every 6 months for a mean period of 30 months (range 6-40), and all new foot ulcers were recorded. The sensitivity, specificity, and positive predictive value of each risk factor were evaluated. RESULTS -Foot ulcers developed in 95 feet (19%) or 73 patients (29%) during the study.Patients who developed foot ulcers were more frequently men, had diabetes for a longer duration, had nonpalpable pedal pulses, had reduced joint mobility, had a high NDS, had a high VPT, and had an inability to feel a 5.07 SWF. NDS alone had the best sensitivity, whereas the combination of the NDS and the inability to feel a 5.07 SWF reached a sensitivity of 99%. On the other hand, the best specificity for a single factor was offered by foot pressures, and the best combination was that of NDS and foot pressures. Univariate logistical regression analysis yielded a statistically significant odds ratio (OR) for sex, race, duration of diabetes, palpable pulses, history of foot ulceration, high NDSs, high VPTs, high SWFs, and high foot pressures. In addition, 94 (99%) of the 95 ulcerated feet had a high NDS and/or SWF, which resulted in the highest OR of . Furthermore, in multivariate logistical regression analysis, the only significant factors were high NDSs, VPTs, SWFs, and foot pressures.CONCLUSIONS -Clinical examination and a 5.07 SWF test are the two most sensitive tests in identifying patients at risk for foot ulceration, especially when the tests are used in conjunction with each other. VPT measurements are also helpful and can be used as an alternative. Finally, foot pressure measurements offer a substantially higher specificity and can be used as a postscreening test in conjunction with providing appropriate footwear.

OBJECTIVE -To compare the effectiveness of total-contact casts (TCCs), removable cast walkers (RCWs), and half-shoes to heal neuropathic foot ulcerations in individuals with diabetes.RESEARCH DESIGN AND METHODS -In this prospective clinical trial, 63 patients with superficial noninfected, nonischemic diabetic plantar foot ulcers were randomized to one of three off-loading modalities: TCC, half-shoe, or RCW. Outcomes were assessed at wound healing or at 12 weeks, whichever came first. Primary outcome measures included proportion of complete wound healing at 12 weeks and activity (defined as steps per day).RESULTS -The proportions of healing for patients treated with TCC, RCW, and half-shoe were 89.5, 65.0, and 58.3%, respectively. A significantly higher proportion of patients were healed by 12 weeks in the TCC group when compared with the two other modalities (89.5 vs. 61.4%, P ϭ 0.026, odds ratio 5.4, 95% CI 1.1-26.1). There was also a significant difference in survival distribution (time to healing) between patients treated with a TCC and both an RCW (P ϭ 0.033) and half-shoe (P ϭ 0.012). Patients were significantly less active in the TCC (600.1 Ϯ 320.0 daily steps) compared with the half-shoe (1,461.8 Ϯ 1,452.3 daily steps, P ϭ 0.04). There was no significant difference in the average number of steps between the TCC and the RCW (767.6 Ϯ 563.3 daily steps, P ϭ 0.67) or the RCW and the half-shoe (P ϭ 0.15).CONCLUSIONS -The TCC seems to heal a higher proportion of wounds in a shorter amount of time than two other widely used off-loading modalities, the RCW and the half-shoe. Diabetes Care 24:1019 -1022, 2001N europathic ulcers are the prime precipitant of diabetes-related amputations of the lower extremity (1). The central goal of any treatment program designed to heal these wounds is effective reduction in pressure (off-loading) (2). Total-contact casts (TCCs) are considered the gold standard of ulcer treatment by many experts in this field (3-16). This assertion, however, has been made ostensibly without any meaningful side-byside comparison of devices. Our and other investigators' systematic reviews have been unable to identify any studies that prospectively compare the clinical effectiveness of various prosthetic devices with off-load ulcer sites to facilitate wound healing (17). Therefore, the purpose of this study was to compare the effectiveness of TCCs, removable cast walkers (RCWs), and half-shoes to heal neuropathic foot ulcerations in individuals with diabetes.RESEARCH DESIGN AND METHODS -In this prospective clinical trial, 63 patients were randomized into one of three off-loading modalities, including TCC, half-shoe (Darco, Huntington, WV), or the Aircast diabetic walker (Aircast, Summit, NJ). The diagnosis of diabetes had been made before enrollment and was confirmed either by communication with primary care providers or by reviewing medical records. All patients had clinically significant loss of protective sensation (Ͼ25 V) as measured with a biothesiometer (Biomedical Instrument, Newbury, OH) (18,...

A Comparison of Two Diabetic Foot Ulcer Classification SystemsThe Wagner and the University of Texas wound classification systemsOBJECTIVE -In this study, the following two ulcer classification systems were applied to new foot ulcers to compare them as predictors of outcome: the Wagner (grade) and the University of Texas (UT) (grade and stage) wound classification systems.RESEARCH DESIGN AND METHODS -Ulcer size, appearance, clinical evidence of infection, ischemia, and neuropathy at presentation were recorded, and patients were followed up until healing or for 6 months.RESULTS -Of 194 patients with new foot ulcers, 67.0% were neuropathic, 26.3% were neuroischemic, 1.0% were ischemic, and 5.7% had no identified underlying factors. Median (interquartile range [IQR]) ulcer size at presentation was 1.5 cm 2 (0.6-4.0). Lower-limb amputations were performed for 15% of ulcers, whereas 65% healed [median (IQR) healing time 5 (3-10) weeks] and 16% were not healed at study termination; 4% of patients died. Wagner grade (P Ͻ 0.0001), and UT grade (P Ͻ 0.0001) and stage (P Ͻ 0.001) showed positive trends with increased number of amputations. For UT stage, the risk of amputation increased with infection both alone (odds ratio [OR] = 11.1, P Ͻ 0.0001) and in combination with ischemia (OR = 14.7, P Ͻ 0.0001), but not significantly with ischemia alone (OR = 4.6, P = 0.09). Healing times were not significantly different for each grade of the Wagner (P = 0.1) or the UT system (P = 0.07), but there was a significant stepwise increase in healing time with each stage of the UT system (P Ͻ 0.05), and stage predicted healing (P Ͻ 0.05).CONCLUSIONS -Increasing stage, regardless of grade, is associated with increased risk of amputation and prolonged ulcer healing time. The UT system' s inclusion of stage makes it a better predictor of outcome.