Topical Oxygen Therapy: Its Time Has Come

Introduction: Topical Oxygen Therapy (TOT) has been used clinically for over 50 years with many case series and open label cohort studies supporting its role in wound care. While opponents inferred that TOT could not affect wound repair, recent randomized, controlled trials (RCTs) and systematic reviews clearly demonstrate efficacy in healing chronic diabetic foot ulcers (DFU). We herein summarize the most recent evidence in support of TOT as a proven advanced therapy for hard-to-heal DFUs.Methods:A review of level 1 and 2 studies published over the previous decade including only RCTs and Systematic Reviews (with meta-analyses when available) was undertaken. Observational studies were not considered. We summarized the high-level evidence and combined the meta-analyses to determine the odds ratio (OR) associations of TOT with complete healing of DFUs at 12 weeks compared to controls.Results:4 robust RCTs were identified having been published since 2017. Three of the 4 were blinded allocations with sham controls while one was open label. Six total systematic reviews on TOT for DFUs have been published since 2019, five with meta-analyses. Although studies included in the meta-analyses differed somewhat and had different degrees of bias, all yielded a significant effect for DFU healing at 12 weeks compared to controls ranging from OR 1.59 to OR 2.49. The most robust meta-analysis of only RCTs yielded a risk ratio (RR) of 1.59; p=0.021).Discussion: This summary review of the highest-level evidence for TOT for healing DFUs indicates the indisputable efficacy of this adjunctive therapy.References:1. V. Driver, A. Reyzelman, J. Kawalec and M. French. A Prospective, Randomized, Blinded, Controlled Trial Comparing Transdermal Continuous Oxygen Delivery to Moist Wound Therapy for the Treatment of Diabetic Foot Ulcers. Ostomy Wound Manage 2017 Vol. 63 Issue 4 Pages 12-28 2. M. Q. Niederauer, J. E. Michalek and D. G. Armstrong. A Prospective, Randomized, Double-Blind Multicenter Study Comparing Continuous Diffusion of Oxygen Therapy to Sham Therapy in the Treatment of Diabetic Foot Ulcers. J Diabetes Sci Technol 2017 Vol. 11 Issue 5 Pages 883-891 3. R. G. Frykberg, P. J. Franks, M. Edmonds, J. N. Brantley, L. Teot, T. Wild, et al. 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 Vol. 43 Issue 3 Pages 616-624 4. T. E. Serena, N. M. Bullock, W. Cole, et al. Topical oxygen therapy in the treatment of diabetic foot ulcers: a multicentre, open, randomised controlled clinical trial. J Wound Care 2021 Sup5 Pages S7-S14 5. M. J. Carter, R. G. Frykberg, A. Oropallo, et al. Efficacy of Topical Wound Oxygen Therapy in Healing Chronic Diabetic Foot Ulcers: Systematic Review and Meta-Analysis. Adv Wound Care (New Rochelle) 2023 Vol. 12 Issue 4 Pages 177-186 6. A. Sethi, Y. Khambhaytab and P. Vas. Topical oxygen therapy for healing diabetic foot ulcers: A systematic review and meta- analysis of randomised control trials. Health Sciences Review 2022 Vol. 3