Piaggesi A, Macchiarini S, Rizzo L, Palumbo F, Tedeschi A, Nobili LA, Leporati E, Scire V, Teobaldi I, Del Prato S, et al.
Diabetes care. Date of publication 2007 Mar 1;volume 30(3):586-90.
1. Diabetes Care. 2007 Mar;30(3):586-90.
An off-the-shelf instant contact casting device for the management of diabetic
foot ulcers: a randomized prospective trial versus traditional fiberglass cast.
Piaggesi A(1), Macchiarini S, Rizzo L, Palumbo F, Tedeschi A, Nobili LA, Leporati
E, Scire V, Teobaldi I, Del Prato S.
Author information:
(1)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
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.
DOI: 10.2337/dc06-1750
PMID: 17327325 [Indexed for MEDLINE]
