title: An off-the-shelf instant contact casting device for the management of diabetic foot ulcers: a randomized prospective trial versus traditional fiberglass cast.
abstract: OBJECTIVE
  This study was designed to test the safety, effectiveness, and costs of off-loading with a novel, off-the-shelf irremovable device in the management of diabetic foot ulceration (DFU).
  
  
  METHODS
  We prospectively evaluated off-loading of neuropathic plantar ulcers in 40 diabetic outpatients attending our diabetic foot clinic and compared healing rates at the 12-week follow-up, number and severity of adverse events, healing time, costs and applicability of the device, and patients' satisfaction between those randomly assigned to total contact casting (TCC; group A) or to the Optima Diab walker (group B). Deep or infected ulcers were excluded.
  
  
  RESULTS
  No difference between groups A and B was observed in healing rates at 12 weeks (95 vs. 85%), healing time (6.5 +/- 4.4 vs. 6.7 +/- 3.4 weeks), and number of adverse events (six versus four). Treatment was significantly less expensive in group B, which showed a mean reduction of costs of 78% compared with group A (P < 0.001). Practicability was more favorable in group B, with a reduction of 77 and 58% of the time required for application and removal of the devices, respectively (P < 0.001). Patients' satisfaction with the treatment was higher in group B (P < 0.01).
  
  
  CONCLUSIONS
  The Optima Diab walker is as safe and effective as TCC in the management of DFU, but its lower costs and better applicability may be of help in spreading the practice of off-loading among the centers that manage the diabetic foot.
authors.affiliation: Section of Diabetes and Metabolic Diseases, Department of Endocrinology and Metabolism, University of Pisa and Azienda Ospedaliera Pisana, Pisa, Italy. piaggesi@immr.med.unipi.it
authors.forename: Alberto
authors.initials: A
authors.lastname: Piaggesi
authors.forename: Silvia
authors.initials: S
authors.lastname: Macchiarini
authors.forename: Loredana
authors.initials: L
authors.lastname: Rizzo
authors.forename: Francesca
authors.initials: F
authors.lastname: Palumbo
authors.forename: Anna
authors.initials: A
authors.lastname: Tedeschi
authors.forename: Laura Ambrosini
authors.initials: LA
authors.lastname: Nobili
authors.forename: Elisa
authors.initials: E
authors.lastname: Leporati
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Scire
authors.forename: Ilaria
authors.initials: I
authors.lastname: Teobaldi
authors.forename: Stefano
authors.initials: S
authors.lastname: Del Prato
mesh_terms: D000368:Aged; D002370:Casts, Surgical; D003922:Diabetes Mellitus, Type 1 / Q000150:complications; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D017719:Diabetic Foot / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D004867:Equipment Design; D016523:Foot Ulcer / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D016019:Survival Analysis
chemical_list: D006442:Glycated Hemoglobin