A randomized trial of two irremovable off-loading devices in the management of plantar neuropathic diabetic foot ulcers

Diabetes Care. 2005 Mar;28(3):555-9. doi: 10.2337/diacare.28.3.555.

Abstract

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Casts, Surgical*
  • Diabetic Foot / therapy*
  • Diabetic Neuropathies / therapy
  • Equipment Design
  • Female
  • Humans
  • Male
  • Middle Aged
  • Perception
  • Tibial Neuropathy / therapy
  • Time Factors
  • Treatment Outcome
  • Vibration
  • Weight-Bearing*