Hyperbaric Oxygen Therapy Combined With Standard Wound Care Versus Standard Wound Care Alone in Patients With Diabetic Foot Ulcers: A Prospective Comparative Study.

Background Non-healing diabetic foot ulcers (DFUs) are significant risk factors for amputations. Though the available literature suggests that adjuvant hyperbaric oxygen therapy (HBOT) fastens the healing process and reduces the risk of amputations, its overall evidence in the reduction of amputation remains controversial. Thus, the present study aimed to compare the efficacy and safety of adjuvant HBOT and standard wound care (SWC) with SWC alone in patients with DFUs. Methods This prospective, randomized, controlled study involved 60 adult patients with DFU. Based on the simple random number table, the patients were equally randomized into two group: adjuvant HBOT and SWC (n=30) with SWC alone (n=30). The patients received 24 sessions (six sessions per week) of HBOT (3.0 absolute atmospheric pressure) for 45 minutes daily over a period of four consecutive weeks. The outcome measures included wound size reduction, wound bed condition, complications, and proportion of patients undergoing amputation. The patients were assessed at four-week follow-up. Results At four weeks, both the groups had a significant reduction in pain score, wound size, and inflammation of the surrounding skin compared to baseline (all p<0.001). At the end of the study, the adjuvant HBOT and SWC group had significantly reduced pain score and wound size as well as a greater proportion of healthy granulation tissue in the wound bed relative to the SWC group (all p=0.001). Moreover, adjuvant HBOT and SWC led to a significantly reduced incidence of minor amputation (p=0.001), while complications were comparable between the groups (p=0.198). Conclusion Adjuvant HBOT and SWC are more effective than SWC in healing the DFUs and reduction of minor amputations.