title: Comparison of Removable and Irremovable Walking Boot to Total Contact Casting in Offloading the Neuropathic Diabetic Foot Ulceration.
abstract: BACKGROUND
  Despite its efficacy in healing neuropathic diabetic foot ulcers (DFUs), total contact cast (TCC) is often underused because of technical limitations and poor patient acceptance. We compared TCC to irremovable and removable commercially available walking boots for DFU offloading.
  
  
  METHODS
  We prospectively studied 60 patients with DFUs, randomly assigned to 3 different offloading modalities: TCC (group A), walking boot rendered irremovable (i-RWD; group B), and removable walking boot (RWD; group C). Patients were followed up weekly for 90 days or up to complete re-epithelization; ulcer survival, healing time, and ulcer size reduction (USR) were considered for efficacy, whereas number of adverse events was considered for safety. Patients' acceptance and costs were also evaluated.
  
  
  RESULTS
  Mean healing time in the 3 groups did not differ (P = .5579), and survival analysis showed no difference between the groups (logrank test P = .8270). USR from baseline to the end of follow-up was significant (P < .01) in all groups without differences between the groups. Seven patients in group A (35%), 2 in group B (10%), and 1 in group C (5%) (Fisher exact test P = .0436 group A vs group C) reported nonsevere adverse events. Patients' acceptance and costs were significantly better in group C (P < .05).
  
  
  CONCLUSIONS
  Our results suggest that a walking boot was as effective and safe as TCC in offloading the neuropathic DFUs, irrespective of removability. The better acceptability and lesser costs of a removable device may actually extend the possibilities of providing adequate offloading.
  
  
  METHODS
  Level II, prospective comparative study.
authors.affiliation: Sezione Dipartimentale Piede Diabetico, Dipartimento di Area Medica, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy piaggesi@immr.med.unipi.it.
authors.forename: Alberto
authors.initials: A
authors.lastname: Piaggesi
authors.affiliation: Sezione Dipartimentale Piede Diabetico, Dipartimento di Area Medica, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Goretti
authors.affiliation: Sezione Dipartimentale Piede Diabetico, Dipartimento di Area Medica, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Iacopi
authors.affiliation: Centro per la Cura del Piede Diabetico, Istituto di Cura Città di Pavia, Pavia, Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Clerici
authors.affiliation: U.O.C. Centro Piede Diabetico, Istituto nazionale ricovero e cura anziani, Ancona, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Romagnoli
authors.affiliation: U.O. Piede Diabetico e ferite difficili. Casa di cura accreditata Villa Tiberia Roma, Roma, Italy.
authors.forename: Fabrizia
authors.initials: F
authors.lastname: Toscanella
authors.affiliation: Centro Regionale Specialistico per la Diagnosi e Cura del Piede Diabetico. Azienda Ospedaliero-Universitaria di Perugia, Perugia, Italy.
authors.forename: Cristiana
authors.initials: C
authors.lastname: Vermigli
mesh_terms: D000368:Aged; D002370:Casts, Surgical; D017719:Diabetic Foot / Q000503:physiopathology / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011446:Prospective Studies; D012775:Shoes; D016138:Walking; D016474:Weight-Bearing; D014945:Wound Healing
keywords: compliance; cost-effectiveness; diabetic foot; irremovable walking boot; offloading; removable walking boot; total contact cast