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.
Ulcer area, a measure of ulcer size, predicts the outcome of foot ulcers. Its inclusion into a diabetic wound classification system will make that system a better predictor of outcome.
Background: The purpose of this study was to determine the degree to which pressure on the plantar aspect of the forefoot is reduced following percutaneous lengthening of the Achilles tendon in diabetic patients who are at high risk for ulceration of the foot.Methods: Ten diabetic patients who had a history of neuropathic plantar ulceration of the forefoot were enrolled in a laboratory gait trial. A repeated-measures design and a computer analysis of force-plate data were used to examine dynamic pressures on the forefoot, with the patient walking barefoot, immediately before percutaneous lengthening of the Achilles tendon and at eight weeks afterward. Although the wound in each patient had healed at least one month before the operation, we considered the patients to be at high risk for ulceration because they had had an ulcer previously.Results: The mean peak pressure (and standard deviation) on the plantar aspect of the forefoot decreased significantly from 86 ± 9.4 newtons per square centimeter preoperatively to 63 ± 13.2 newtons per square centimeter at eight weeks postoperatively (p < 0.001). Commensurately, the mean dorsiflexion of the ankle joint increased significantly from 0 ± 3.1 degrees preoperatively to 9 ± 2.3 degrees at eight weeks postoperatively (p < 0.001).Conclusions: The results of this study suggest that peak pressures on the plantar aspect of the forefoot are significantly reduced following percutaneous lengthening of the Achilles tendon in diabetic patients who are at high risk for ulceration of the foot. We are unaware of any other reports in the medical literature that describe such findings. These data may lend support to studies that have indicated that this procedure should be used as an adjunctive therapeutic or prophylactic measure to reduce the risk of neuropathic ulceration.
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