A systematic review and meta-analysis of hyperbaric oxygen therapy for diabetic foot ulcers with arterial insufficiency.

BACKGROUND: Diabetic foot ulcers (DFUs) are frequently associated with peripheral arterial occlusive disease (PAOD) and may ultimately lead to amputations of the lower extremity. Adjuvant hyperbaric oxygen treatment (HBOT) might foster better wound healing and lower amputation rates in patients with DFU and PAOD. A systematic review was conducted to assess the effects of HBOT as an adjunctive therapy to standard treatment for patients with DFUs with PAOD. METHODS: Systematic review using the MEDLINE, EMBASE, and Cochrane CENTRAL databases (from inception to October 2018). All original, comparative studies on the effect of HBOT on DFUs with PAOD were eligible. The primary outcome measures were amputation rate, amputation-free survival, complete ulcer healing, and mortality. RESULTS: Eleven studies, totaling 729 patients, were included for analysis, including 7 randomized clinical trials, 2 controlled clinical trials, and 2 retrospective cohorts. Four were used for quantitative synthesis. Meta-analysis showed a significantly fewer major amputations in the HBOT group (10.7% vs 26.0%; risk difference, -15%; 95% confidence interval [CI], -25 to -6; P = .002; number needed to treat, 7; 95% CI, 4-20). No difference was found for minor amputations (risk difference, 8%; 95% CI, -13 to 30; P = .46). Three studies reporting on complete wound healing showed contrasting results. No significant difference was found for mortality or amputation-free survival. CONCLUSIONS: Current evidence shows that adjuvant HBOT improves major amputation rate, but not wound healing, in patients with DFUs and PAOD. Given the wide range of patients included in the trials, better patient selection may help define which patients with DFUs and PAOD benefit most from HBOT as standard adjunctive treatment.