Cycled hyperbaric oxygen improves the healing of diabetic foot ulcers

Reference

Frykberg RG, Franks PJ, Edmonds M, et al, for the TWO2 Study Group. 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. Diabetes Care 2020;43(3):616-624.

Synopsis

These investigators enrolled 73 patients with diabetes who had been recruited from wound centers. The patients had full-thickness DFUs between 1 cm2 and 19 cm2 and had been treated for at least 4 weeks. They were observed for an additional 2 weeks, treated with dressing and a rocker sole boot, and were enrolled into the study if they failed to have at least a 30% decrease in wound area with this treatment. Using concealed allocation, the study patients were treated with a closed chamber device that provided hyperbaric oxygen cycled between 10 mb and 50 mb (Hyperbox) or a sham device that circulated nonpressurized ambient air. Patients used the device 90 minutes each day 5 times a week. Using intention-to-treat analysis, after 12 weeks of treatment, 41.7% of patients who received oxygen had complete wound healing as compared with 13.5% who received sham treatment (P = .01). For patients without total healing, oxygen therapy was discontinued and usual care was continued for up to 1 year. By 12 months (9 months after discontinuing hyperbaric oxygen), 56% of patients who received oxygen had complete healing as compared with 27% of patients who received sham treatment. Adverse events were reported in both groups; none were related to the device.