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Hyperbaric oxygen (HBO) therapy is a controversial intervention for treating patients with chronic diabetic foot ulcers. Several previous randomized trials suggested benefit but had various limitations.
In this double-blind randomized trial from Canada, 103 diabetic patients with chronic nonhealing foot ulcers received either HBO or sham therapy, given 5 days weekly for 6 weeks. Patients in both groups received standard comprehensive wound care. At 12 weeks (6 weeks after HBO or sham treatments concluded), a vascular surgeon who was blinded to treatment assignment reviewed each patient's clinical course — including serial photographs of the wound — and decided whether the patient met prespecified criteria for amputation.
The proportions of pa…