Katz IA, Harlan A, Miranda-Palma B, Prieto-Sanchez L, Armstrong DG, Bowker JH, Mizel MS, Boulton AJ, et al.
Diabetes care. Date of publication 2005 Mar 1;volume 28(3):555-9.
1. Diabetes Care. 2005 Mar;28(3):555-9.
A randomized trial of two irremovable off-loading devices in the management of
plantar neuropathic diabetic foot ulcers.
Katz IA(1), Harlan A, Miranda-Palma B, Prieto-Sanchez L, Armstrong DG, Bowker JH,
Mizel MS, Boulton AJ.
Author information:
(1)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.
PMID: 15735187 [Indexed for MEDLINE]