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

Area of Science:

• Vascular Surgery
• Wound Healing
• Hyperbaric Medicine

Background:

• Chronic venous leg ulcers (CVLUs) are prevalent, affecting 1%-3% of adults.
• Standard compression therapy has limited efficacy, with healing rates between 40%-70% at 24 weeks.
• Evidence for hyperbaric oxygen (HBO) therapy in CVLU treatment remains controversial due to limited sham-controlled trials.

Purpose of the Study:

• To evaluate the efficacy of adjunctive hyperbaric oxygen (HBO) therapy in improving the healing of refractory chronic venous leg ulcers (CVLUs) compared to standard care alone.

Main Methods:

• An open-label, single-centre randomized trial involving 80 adults with CVLUs unresponsive to standard care for over 3 months.
• Participants were randomized to receive either HBO (20 sessions at 2.4 ATA for 90 minutes) plus standard care or standard care alone.
• Ulcer area reduction was measured at 30 days as the primary outcome, with complete healing assessed at 90 days.

Main Results:

• The HBO group demonstrated significantly greater ulcer area reduction (62.1% vs. 41.7%; p < 0.001) at 30 days.
• Complete healing by 90 days was achieved in 62.5% of the HBO group compared to 30.0% in the standard care group (NNT=3).
• Adjunctive HBO also led to increased transcutaneous oxygen levels (TcPO2) and greater pain reduction.

Conclusions:

• Adjunctive HBO therapy appears to accelerate short-term healing of refractory chronic venous leg ulcers, particularly for smaller wounds (<20 cm²).
• The study's open-label, single-centre design limits definitive conclusions.
• Further sham-controlled, multicentre trials with longer follow-up are necessary to confirm these findings and guide routine clinical recommendations.