Key Message
Evidence regarding the clinical efficacy of continuously diffused oxygen was identified in three unique randomized controlled trials and a systematic review. The key contributions to the findings of this report were from two recently published, double-blinded, placebo controlled, randomized controlled trials associated with few methodological limitations, however both observed high patient attrition. These two studies had conflicting findings which prevented evidence-based conclusions regarding clinical efficacy of continuously diffused oxygen for patients with diabetic foot ulcers. Limited evidence from these studies suggested that the patient population most likely to benefit from continuously diffused oxygen treatment of diabetic foot ulcers has yet to be defined. Two smaller unblinded randomized controlled trials, one identified in the systematic review, observed benefits of continuously derived oxygen for diabetic foot ulcers but both were associated with methodological limitations. While consensus was reached in all identified evidence that continuously diffused oxygen is safe, the best safety evidence was from patients with diabetic foot ulcers and limited comorbidities. For patients with other chronic wounds, evidence for the efficacy of continuously diffused oxygen was generally favourable however this evidence consisted of two small case series identified by the systematic review included in this report. No evidence regarding the cost-effectiveness of continuously diffused oxygen therapy was identified. Relevant guidelines from the International Working Group of the Diabetic Foot were published in 2020. The guideline development group recommended not to use topical oxygen therapy, of which continuously diffused oxygen is a subtype, as a primary or adjunctive intervention for diabetic foot ulcers. The strength of this recommendation was weak, and it rated the supporting evidence as low quality. Further studies to resolve the conflicting evidence identified in this report, and further studies on patients with chronic wounds other than diabetic foot ulcers, are required before an evidence-based assessment of the potential role for continuously diffused oxygen therapy in wound healing can be well established.