Hyperbaric Oxygen Therapy for Chronic Venous Leg Ulcers: A Prospective Randomised Controlled Trial

ABSTRACT

Chronic venous leg ulcers (CVLUs) affect 1%–3% of adults. Standard compression therapy achieves healing in only 40%–70% of cases at 24 weeks. Evidence for hyperbaric oxygen (HBO) therapy remains controversial, with limited sham-controlled trials. To evaluate whether adjunctive HBO improves healing of refractory CVLUs compared to standard care alone. Single-centre, open-label randomised trial of 80 adults with CVLUs that persisted > 3 months despite standard care (defined as < 30% area reduction after 4 weeks of compression therapy). All consecutive eligible patients were randomised to HBO (20 sessions at 2.4 ATA, 90 min) plus standard care (n = 40) or standard care alone (n = 40). Primary outcome: percentage ulcer area reduction at day 30. Blinded assessors measured wounds, though participants knew their treatment allocation. HBO group had greater area reduction (62.1% ± 22.1% vs. 41.7% ± 21.5%; mean difference 20.4%, 95% CI: 10.1–30.7, p < 0.001; Cohen's d = 0.95). Complete healing at 90 days occurred in 62.5% vs. 30.0% (NNT = 3). TcPO₂ increased from 26.1 ± 6.3 to 150.3 ± 45.6 mmHg in HBO group (p < 0.001). Pain decreased more with HBO (ΔVAS −5.0 vs. −1.5, p < 0.001). Three patients (7.5%) had mild ear barotrauma that resolved spontaneously. Main limitations were lack of sham control and 90-day follow-up. In this trial, adjunctive HBO was associated with faster short-term healing of refractory venous ulcers < 20 cm². However, the open-label design and single-centre setting limit confidence in these findings. Sham-controlled multicentre trials with longer follow-up are needed before recommending routine use.