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A Randomized Trial of Two Irremovable Off-Loading Devices in the Management of Plantar Neuropathic Diabetic Foot Ulcers

¹ University of Miami School of Medicine, Miami, Florida
² Tucson Veterans Administration Medical Affairs Center, Tucson, Arizona
³ Scholl’s Center for Lower Extremity Ambulatory Research (CLEAR), Rosalind Franklin University of Medicine and Science, Chicago, Illinois

Address correspondence and reprint requests to Ira A. Katz, MD, 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. E-mail: irakatz{at}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.

Abbreviations: iTCC, irremovable total contact cast • RCW, removable cast walker • TCC, total contact cast • VPT, vibration perception threshold

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