Alberto Piaggesi1, Chiara Goretti2, Elisabetta Iacopi2, Giacomo Clerici3, Fabio Romagnoli4, Fabrizia Toscanella5, Cristiana Vermigli6. 1. Sezione Dipartimentale Piede Diabetico, Dipartimento di Area Medica, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy piaggesi@immr.med.unipi.it. 2. Sezione Dipartimentale Piede Diabetico, Dipartimento di Area Medica, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. 3. Centro per la Cura del Piede Diabetico, Istituto di Cura Città di Pavia, Pavia, Italy. 4. U.O.C. Centro Piede Diabetico, Istituto nazionale ricovero e cura anziani, Ancona, Italy. 5. U.O. Piede Diabetico e ferite difficili. Casa di cura accreditata Villa Tiberia Roma, Roma, Italy. 6. Centro Regionale Specialistico per la Diagnosi e Cura del Piede Diabetico. Azienda Ospedaliero-Universitaria di Perugia, Perugia, Italy.
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. LEVEL OF EVIDENCE: Level II, prospective comparative study.
RCT Entities:
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. LEVEL OF EVIDENCE: Level II, prospective comparative study.
Authors: Sicco A Bus; Jaap J van Netten; Anke Ir Kottink; Erik A Manning; Maximilian Spraul; Arend-Jan Woittiez; Jeff G van Baal Journal: Int Wound J Date: 2017-10-23 Impact factor: 3.315
Authors: Aurelio Perez-Favila; Margarita L Martinez-Fierro; Jessica G Rodriguez-Lazalde; Miguel A Cid-Baez; Michelle de J Zamudio-Osuna; Ma Del Rosario Martinez-Blanco; Fabiana E Mollinedo-Montaño; Iram P Rodriguez-Sanchez; Rodrigo Castañeda-Miranda; Idalia Garza-Veloz Journal: Medicina (Kaunas) Date: 2019-10-25 Impact factor: 2.430
Authors: George N Okoli; Rasheda Rabbani; Otto L T Lam; Nicole Askin; Tanya Horsley; Lorraine Bayliss; Ildiko Tiszovszky; John M Embil; Ahmed M Abou-Setta Journal: BMJ Open Diabetes Res Care Date: 2022-05