Resistant Chronic Venous Leg Ulcers: Effect of Adjuvant Systemic Hyperbaric Oxygen Therapy Versus Venous Intervention Alone.

Abstract

The aim of this study was to assess the adjuvant efficacy of adding systemic hyperbaric oxygen therapy (HBOT) to definitive venous intervention for healing of resistant chronic venous leg ulcers (VLUs). From 97 chronic VLUs, 63 were subjected to a pre-study standard wound care. Thirty three ulcers failed to achieve 50% size reduction, after the 4-weeks standard care, and were allocated to be treated with: HBOT plus venous intervention (n = 17), or venous intervention alone (n = 16). Primary outcomes were the change in ulcer area, complete healing frequency and time, as well as ulcer recurrence. There was a history of recurrent ulcer (82.3% vs. 69%) in HBOT versus venous intervention groups, respectively. The comparison between both groups with regard to area change showed non-significant difference after 3 months of therapy, while there was a significant difference at 6 and 12 months. A significant positive correlation was found between the HBO sessions numbers (20-40) and the rate of ulcer size reduction. Ulcer complete closure after 3 months was observed in (41.7%) of HBOT group, versus (23%) in venous intervention group; (p = 0.33). After 12 months, complete closure was observed in (83.3%) of HBOT group, versus (53.8%) in venous intervention group; (p = 0.02). The mean time of complete closure was significantly shorter in HBOT group, (p = 0.001). HBOT may be effective as adjuvant to venous intervention in treatment of chronic resistant VLUs, it should be reserved for persistent ulcer. Randomized controlled trials with larger numbers is still needed to elucidate its exact role and specific indications.