Comparative Efficacy of Four-Layer Compression Bandage Therapy With and Without Hyperbaric Oxygen Therapy in Venous Leg Ulcer Patients: A Randomized Controlled Trial

Abstract Venous leg ulcers (VLU) are a significant global health challenge, predominantly resulting from chronic venous insufficiency, requiring effective treatment to enhance healing and quality of life. This study aimed to evaluate the efficacy of hyperbaric oxygen therapy (HBOT) in conjunction with four-layer compression bandage (4LCB) therapy in VLU management. A randomized controlled trial was conducted at a tertiary care center in northern India and included 70 patients aged >15 years with chronic venous ulcers. Patients were randomized into two groups: Group A (n = 35) received 4LCB therapy with adjunct HBOT, and Group B (n = 35) received 4LCB therapy alone. Both groups received standard medical therapy, and follow-up assessments were conducted at 2, 4, 6, and 8 weeks. The primary outcomes were reduction in ulcer size and healing time, while secondary outcomes included quality of life assessed using the EQ-5D-5L and Charing Cross questionnaires. Group A showed a significantly greater reduction in ulcer size compared with Group B (p = 0.006). Quality-of-life scores improved significantly in both groups, with Group A demonstrating better Charing Cross scores (p = 0.033). A moderate positive correlation was found between healing time and pre-therapy ulcer size in both groups. VLU affects patients' lives due to pain, difficulty with locomotion, exudate, odor, and repeated hospital visits. It has been proven that multilayered compression bandages, achieving 20 to 30 mm Hg of pressure, effectively reduce venous hypertension, and lead to effective ulcer healing. HBOT has also been shown to be beneficial for VLU in retrospective single-arm studies. This randomized control trial exhibits significant ulcer size reduction and improvement in quality of life in both arms. However, the addition of HBOT to standard 4LCB therapy significantly reduces the mean post-therapy ulcer size and improves post-therapy quality of life in patients with VLU compared with 4LCB therapy alone. There is scope of further studies on the effects of various HBOT regimens on ulcer healing and the use of HBOT in combination with venous surgeries.