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,...

Corneal confocal microscopy is a rapid, non-invasive in vivo clinical examination technique which accurately defines the extent of corneal nerve damage and repair and acts as a surrogate measure of somatic neuropathy in diabetic patients. It could represent an advance to define the severity of neuropathy and expedite assessment of therapeutic efficacy in clinical trials of human diabetic neuropathy.

In general, diabetic foot ulcers result from abnormal mechanical loading of the foot, such as repetitive moderate pressure applied to the plantar aspect of the foot while walking. Diabetic peripheral neuropathy causes changes in foot structure, affecting foot function and subsequently leading to increased plantar foot pressure, which is a predictive risk factor for the development of diabetic foot ulceration. Prevention of diabetic foot ulceration is possible by early identification of the insensitive foot, therefore a foot "at risk," and by protecting the foot from abnormal biomechanical loading. Abnormal foot pressures can be reduced using several different approaches, including callus debridement, prescription of special footwear, injection of liquid silicone, Achilles tendon lengthening, and so forth. Off-loading of the diabetic wound is a key factor in successful wound healing, as it is associated with reduced inflammatory and accelerated repair processes. Pressure relief can be achieved using various off-loading modalities including accommodative dressing, walking splints, ankle-foot orthosis, total contact cast, and removable and irremovable cast walkers.

OBJECTIVE -To investigate the relationship among plantar foot pressure, plantar subcutaneous tissue thickness, severity of neuropathy (vibration perception threshold [VPT]), callus, and BMI in a large group of neuropathic diabetic patients at risk of foot ulceration. RESEARCH DESIGN AND METHODS-A total of 157 diabetic neuropathic patients (VPT Ͼ25 V) without either peripheral vascular or ulcer history were studied. Plantar foot pressure and plantar tissue thickness were measured at each metatarsal head (MTH) using an optical pedobarograph and an ultrasound scanning platform, respectively.RESULTS -A significant association was observed between peak plantar pressure and plantar tissue thickness at all MTHs (Ϫ0.26 Ͻ r Ͻ Ϫ0.61, P Ͻ 0.0001), with the least pronounced association at the first MTH. In addition, the pressure time integral was significantly associated with plantar tissue thickness (Ϫ0.24 Ͻ r Ͻ Ϫ0.57, P Ͻ 0.0001). BMI was significantly related to plantar tissue thickness (0.18 Ͻ r Ͻ 0.45, P Ͻ 0.05), but not to peak forefoot pressures. Subjects with callus had significantly reduced plantar tissue thickness at all MTHs except the first MTH and increased peak pressures at all MTHs (P Ͻ 0.001).CONCLUSIONS -This study confirms a strong inverse relationship between plantar tissue thickness and dynamic foot pressure measurements. Long-term follow-up of this patient population will confirm whether reduced plantar tissue thickness predicts the development of diabetic foot ulcers.