Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Miami, DRI Building, 1450 N.W. 10th Ave., Room 3054, P.O. Box 016960 (D110), Miami, FL 33101, USA. irakatz@bellsouth.net
OBJECTIVE: The purpose of this study was to compare the effectiveness of a removable cast walker (RCW) rendered irremovable (iTCC) with the total contact cast (TCC) in the treatment of diabetic neuropathic plantar foot ulcers. RESEARCH DESIGN AND METHODS: In a prospective, randomized, controlled trial, 41 consecutive diabetic patients with chronic, nonischemic, neuropathic plantar foot ulcers were randomly assigned to one of two groups: a RCW rendered irremovable by wrapping it with a single layer of fiberglass casting material (i.e., an iTCC) or a standard TCC. Primary outcome measures were the proportion of patients with ulcers that healed at </=12 weeks, healing rates, complication rates, cast placement/removal times, and costs. RESULTS: The proportions of patients with ulcers that healed within 12 weeks in the iTCC and TCC groups were 80 and 74%, respectively (94 and 93%, respectively, when patients who were lost to follow-up were excluded). Survival analysis (healing rates) was statistically equivalent in the two groups, as were complication rates, but with a trend toward benefit in the iTCC group. The iTCC took significantly less time to place and remove than the TCC with 39% and 36% reductions, respectively. There was also an overall lower cost associated with the use of the iTCC compared with the TCC. CONCLUSIONS: The iTCC may be equally efficacious, faster to place, easier to use, and less expensive than the TCC in the treatment of diabetic plantar neuropathic foot ulcers.