A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study

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Main idea: This sham-controlled, double-blind randomized controlled trial demonstrates that, at both 12 weeks and 12 months, adjunctive cyclical pressurized Topical Wound Oxygen therapy was superior in healing chronic DFUs compared with optimal standard of care alone.

Abstract

Objective: Topical oxygen has been used for the treatment of chronic wounds for more than 50 years. Its effectiveness remains disputed due to the limited number of robust high-quality investigations. The aim of this study was to assess the efficacy of multimodality cyclical pressure Topical Wound Oxygen home care therapy in healing refractory diabetic foot ulcers (DFUs) that had failed to heal with standard of care alone.

Results: At the first analysis point, the active Topical Wound Oxygen arm was found to be superior to the sham arm, with a closure rate of 41.7% compared with 13.5%. At 12 months postenrollment, 56% of active arm ulcers were closed compared with 27% of the sham arm ulcers.

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