An Off-the-Shelf Instant Contact Casting Device for the Management of Diabetic Foot Ulcers A randomized prospective trial versus traditional fiberglass cast

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 ulcer-ation (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 wasmore 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 i