title: Effect of custom-made footwear on foot ulcer recurrence in diabetes: a multicenter randomized controlled trial.
abstract: OBJECTIVE
  Custom-made footwear is the treatment of choice to prevent foot ulcer recurrence in diabetes. This footwear primarily aims to offload plantar regions at high ulcer risk. However, ulcer recurrence rates are high. We assessed the effect of offloading-improved custom-made footwear and the role of footwear adherence on plantar foot ulcer recurrence.
  
  
  METHODS
  We randomly assigned 171 neuropathic diabetic patients with a recently healed plantar foot ulcer to custom-made footwear with improved and subsequently preserved offloading (∼20% peak pressure relief by modifying the footwear) or to usual care (i.e., nonimproved custom-made footwear). Primary outcome was plantar foot ulcer recurrence in 18 months. Secondary outcome was ulcer recurrence in patients with an objectively measured adherence of ≥80% of steps taken.
  
  
  RESULTS
  On the basis of intention-to-treat, 33 of 85 patients (38.8%) with improved footwear and 38 of 86 patients (44.2%) with usual care had a recurrent ulcer (relative risk -11%, odds ratio 0.80 [95% CI 0.44-1.47], P = 0.48). Ulcer-free survival curves were not significantly different between groups (P = 0.40). In the 79 patients (46% of total group) with high adherence, 9 of 35 (25.7%) with improved footwear and 21 of 44 (47.8%) with usual care had a recurrent ulcer (relative risk -46%, odds ratio 0.38 [0.15-0.99], P = 0.045).
  
  
  CONCLUSIONS
  Offloading-improved custom-made footwear does not significantly reduce the incidence of plantar foot ulcer recurrence in diabetes compared with custom-made footwear that does not undergo such improvement, unless it is worn as recommended.
authors.affiliation: Corresponding author: Sicco A. Bus, s.a.bus@amc.uva.nl.
authors.forename: Sicco A
authors.initials: SA
authors.lastname: Bus
authors.forename: Roelof
authors.initials: R
authors.lastname: Waaijman
authors.forename: Mark
authors.initials: M
authors.lastname: Arts
authors.forename: Mirjam
authors.initials: M
authors.lastname: de Haart
authors.forename: Tessa
authors.initials: T
authors.lastname: Busch-Westbroek
authors.forename: Jeff
authors.initials: J
authors.lastname: van Baal
authors.forename: Frans
authors.initials: F
authors.lastname: Nollet
mesh_terms: D017719:Diabetic Foot / Q000453:epidemiology / Q000503:physiopathology / Q000534:rehabilitation*; D018450:Disease Progression; D004867:Equipment Design; D005500:Follow-Up Studies; D005528:Foot / Q000503:physiopathology*; D006801:Humans; D015994:Incidence; D009426:Netherlands / Q000453:epidemiology; D011312:Pressure; D012008:Recurrence; D012189:Retrospective Studies; D012775:Shoes; D013997:Time Factors; D016896:Treatment Outcome