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). TcPO 2 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 cm 2 . 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.