Efficacy and Safety of Hyperbaric Oxygen Therapy Used in Patients With Diabetic Foot: A Meta-analysis of Randomized Clinical Trials.

Purpose: The efficacy and safety profile of hyperbaric oxygen therapy (HBOT) in patients with diabetic foot ulcer have been controversial in recent years. Our meta-analysis was undertaken to evaluate the efficacy and safety profile of HBOT in patients with diabetic foot ulcer.

Methods: We searched the PubMed, Cochrane Library, EMBASE, and Clinical Trials.gov databases for controlled trials. The efficacy end points included the incidence of healed ulcers, major amputations, minor amputations, and reduction in the ulcer wound area. The tolerability end point was the incidence of adverse events.

Findings: Nine randomized clinical trials involving 526 patients met the inclusion criteria. No difference was found in the incidence of healed ulcers (risk ratio [RR] = 2.22; 95% CI, 0.87-5.62; P = 0.32; I = 81%), minor amputations (RR = 0.95; 95% CI, 0.39-2.29; P = 0.91; I = 74%), major amputations (RR = 0.47; 95% CI, 0.17-1.28; P = 0.14; I = 61%), and adverse events (RR = 1.00; 95% CI, 0.64-1.56; P = 0.99; I = 26%) between the HBOT and standard therapy (ST) groups. HBOT was associated with a greater reduction in the ulcer wound area versus ST (standard mean difference = 1.12; 95% CI, 0.20-2.04; P = 0.04; I = 70%).

Implications: No differences existed between HBOT and ST with respect to the incidence of healed ulcers, risk of minor or major amputations, and adverse events. HBOT was associated with a greater reduction in the ulcer wound area than ST. HBOT is a clinically meaningful adjuvant therapy for patients with diabetic foot ulcer.