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

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). 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.

Effectiveness of Removable Walker Cast Versus Nonremovable Fiberglass Off-Bearing Cast in the Healing of Diabetic Plantar Foot Ulcer

“…Similar results were obtained in previous studies reported by Piaggesi et al (19) and Caravaggi et al (20); however, these two reports differ from our study in two important ways.…”

Off-loading the diabetic foot for ulcer prevention and healing

“…Alternatively, below the knee removable walkers that have been made nonremovable may be as effective as TCCs and more effective than standard removable walkers in healing plantar foot ulcers. [47][48][49] Ulcer healing using removable devices is complicated by patients not adhering to recommendations for using The off-loading capacity of different modalities used for the prevention and treatment of diabetic plantar foot ulcers is expressed as percentage of peak pressure reduction at the first metatarsal head region compared with a control condition. The lighter bars show the range in measured peak pressure reduction over different studies.…”

Health Economics Information in Wound Care: The Elephant in the Room

“…The more complex a task is, in basic wound care, the less likely it will be carried out, properly or even not at all: applying a dressing in a minute is easy, but performing total contact casting (TCC) on a DFU can be challenging for a nonexpert, although instant TCC may ameliorate the problem to some extent. 28 Likewise, clinical practice guidelines-the cornerstone of wound care evaluation-still have a way to go so that clinicians can apply them with immediacy to their work. 29 Finally, inadequate reimbursement has consequences, as noted by Bolton et al: ''Sufficient evidence supports improved venous ulcer care in the U.S. but inadequate and/or inconsistent reimbursement policies impede quality evidence-based venous ulcer practice, delaying healing and increasing the burden of venous ulcers on society.''…”