title: Off-loading the diabetic foot wound: a randomized clinical trial.
abstract: 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.
  
  
  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 = 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 = 0.033) and half-shoe (P = 0.012). Patients were significantly less active in the TCC (600.1 +/- 320.0 daily steps) compared with the half-shoe (1,461.8 +/- 1,452.3 daily steps, P = 0.04). There was no significant difference in the average number of steps between the TCC and the RCW (767.6 +/- 563.3 daily steps, P = 0.67) or the RCW and the half-shoe (P = 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.
authors.affiliation: Audie L. Murphy Veterans Affairs Medical Center, Tucson, AZ 85723, USA. armstrong@usa.net
authors.forename: D G
authors.initials: DG
authors.lastname: Armstrong
authors.forename: H C
authors.initials: HC
authors.lastname: Nguyen
authors.forename: L A
authors.initials: LA
authors.lastname: Lavery
authors.forename: C H
authors.initials: CH
authors.lastname: van Schie
authors.forename: A J
authors.initials: AJ
authors.lastname: Boulton
authors.forename: L B
authors.initials: LB
authors.lastname: Harkless
mesh_terms: D002370:Casts, Surgical; D003646:Debridement; D017719:Diabetic Foot / Q000503:physiopathology / Q000628:therapy*; D003929:Diabetic Neuropathies / Q000503:physiopathology; D005260:Female; D016523:Foot Ulcer / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D009460:Neurologic Examination; D012775:Shoes; D013997:Time Factors; D016896:Treatment Outcome; D016474:Weight-Bearing; D014945:Wound Healing