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Efficacy, safety, and compliance
OBJECTIVE - To compare the efficacy, safety, and compliance of a nonremovable fiberglass cast boot and off-loading shoes in the treatment of diabetic plantar ulcers.
RESEARCH DESIGN AND METHODS- Patients (n = 93) with noninfected, nonischemic plantar ulcers were included in this prospective nonrandomized study. Treatment used a nonremovable fiberglass cast boot for longer standing and deeper ulcers (n = 42) and a half shoe or heel-relief shoe for other ulcers (n = 51). We evaluated off-loading therapy, compliance, and complications in both groups.
RESULTS - The healing rate was significantly higher with the cast boot than with the off-loading shoe (81 vs. 70%, P = 0.017), with healing times of 68.6 + or - 35.1 vs. 134.2 + or - 133.0 days, respectively, and hazard ratio 1.68 (95% Cl 1.04-2.70); complete compliance with treatment was 98 vs. 10% (P = 0.001), respectively. Secondary osteomyelitis developed in 3 patients in the cast boot group and 13 patients in the off-loading shoe group (P = 0.026).
CONCLUSIONS - A nonremovable fiberglass cast boot was effective in healing diabetic plantar ulcers and in decreasing the risk of secondary osteomyelitis. The cast boot forced compliance with off-loading, thus promoting healing.
Abbreviations: ABI, ankle-brachial index; TCC, total contact cast.
A table elsewhere in this issue shows conventional and Systeme International (SI) units and conversion factors for many substances.
(C) 2003 by the American Diabetes Association.
Delayed healing of diabetic plantar ulcers is caused primarily by inadequate or inappropriate wound off-loading. It has been suggested that "untreated ulcer" may be a better term than "recalcitrant ulcer" when off-loading is suboptimal (1).
Neuropathy is the main cause of plantar ulcers in patients with diabetes. The wounds develop in insensitive areas subjected to excessive pressure (2). The loss of sensation in the foot results in diagnostic and therapeutic delays and is a major obstacle to compliance with treatments, particularly off-loading. Suboptimal off-loading is associated with an increased risk of wound infection. The infection can spread to the soft tissues, causing cellulitis of the foot, or to the underlying bone. Cellulitis and osteomyelitis can occur concomitantly; both complications greatly increase the risk of amputation.
Clinical studies have established that off-loading by a total contact cast (TCC)...