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Diabetes Care 30:586-590, 2007
DOI: 10.2337/dc06-1750
© 2007 by the American Diabetes Association
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Emerging Treatments and Technologies
Original Article

An Off-the-Shelf Instant Contact Casting Device for the Management of Diabetic Foot Ulcers

A randomized prospective trial versus traditional fiberglass cast

Alberto Piaggesi, MD, Silvia Macchiarini, DPM, Loredana Rizzo, MD, Francesca Palumbo, MD, Anna Tedeschi, MD, Laura Ambrosini Nobili, DPM, Elisa Leporati, DPM, Vincenzo Scire, DPM, Ilaria Teobaldi, DPM and Stefano Del Prato, MD, PHD

From the Section of Diabetes and Metabolic Diseases, Department of Endocrinology and Metabolism, University of Pisa and Azienda Ospedaliera Pisana, Pisa, Italy

Address correspondence and reprint requests to Alberto Piaggesi MD, Sezione Piede Diabetico-U.O., Malattie del Metabolismo e Diabetologia, Azienda Ospedaliera Universitaria Pisana, Via Paradisa 2-56124 Pisa, Italy. E-mail: piaggesi{at}immr.med.unipi.it

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).

RESEARCH DESIGN AND 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.

Abbreviations: DFU, diabetic foot ulceration • i-TCC, instant TCC • RCW, removable cast walker • TCC, total contact casting


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Copyright © 2007 by the American Diabetes Association.