A multinational, multicenter, randomized, double-blinded, placebo-controlled trial to evaluate the efficacy of cyclical Topical Wound Oxygen Therapy (TWO2) in the treatment of chronic diabetic foot ulcers: The TWO2 Study
Diabetes Care Oct 25, 2019
Frykberg RG, Franks PJ, Edmonds M, et al. - In this sham-controlled, double-blind randomized controlled trial, researchers tested the effectiveness of multimodality cyclical pressure Topical Wound Oxygen (TWO2) home care therapy for healing refractory diabetic foot ulcers (DFUs) that were not healed by the standard of care (SOC) alone. They randomized (double-blind) diabetes and chronic DFUs patients to either active TWO2 therapy or sham control therapy—both in addition to optimal SOC. The authors discovered that adjunctive cyclical pressurized TWO2 therapy was superior in chronic DFUs for healing at both 12 weeks and 12 months relative to optimal SOC alone.
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