Topical Oxygen Therapy for Diabetic Foot Ulcers: Updated Evidence From Randomised Trials

To estimate the effect of topical oxygen therapy (TOT) on complete wound closure in diabetic foot ulcers (DFUs) at 12 weeks. We systematically reviewed randomised controlled trials in adults with DFUs comparing TOT to sham or standard care. Study selection and data extraction followed predefined criteria, with uncertainties discussed between the authors. Risk of bias was assessed with RoB 2. The primary outcome was complete closure at 12 weeks. Risk ratios (RRs) were pooled using a Mantel-Haenszel fixed-effect model with χ² and I² to assess heterogeneity. Random-effects sensitivity analyses were performed, including DerSimonian-Laird and Hartung-Knapp adjustment given the small number of studies. Three trials (n = 171 TOT; n = 154 control) reported 12-week closure and were pooled. TOT increased complete closure (RR 1.53, 95% CI 1.14-2.05). Heterogeneity was low (I²≈24%). The DerSimonian-Laird random-effects model produced a similar point estimate (RR 1.50, 95% CI 1.07-2.10), while Hartung-Knapp adjustment yielded wider uncertainty. No zero cells were present; the prespecified continuity correction was not required. Across randomised trials with a 12-week assessment, TOT used alongside standard care increases the likelihood of complete closure in DFUs, with low between-study heterogeneity. These conclusions are based on three pooled randomised trials, and conservative Hartung-Knapp sensitivity analysis widened uncertainty, reflecting the limited size of the evidence base. However, with few trials, uncertainty remains; larger, well-reported studies with standardised endpoints and blinded outcome verification are needed to refine precision and compare delivery approaches.