Hyperbaric Oxygen Therapy in the Treatment of Ischemic Lower-Extremity Ulcers in Patients with Diabetes: Results of the DAMO2CLES Multicenter Randomized Clinical Trial

摘要

To investigate the possible benefits of additional hyperbaric oxygen therapy in patients with diabetes and ischemic leg ulcers. Chronic diabetic foot ulcers (DFUs) are a serious healthcare issue with notable adverse effects on quality of life. Though these ulcers are difficult to treat with conventional treatment and standard care, hyperbaric oxygen therapy (HBOT) is used as an add-on to improve healing rates. Due to unclear research results, DAM02CLES (Does Applying More Oxygen [02] Cure Lower Extremity Sores?) was conducted to assess the curative property of extra oxygen on chronic DFUs. This multicenter, randomized, parallel-group superiority clinical trial was conducted in 24 hospitals in Belgium (n = 120). An interim safety and effectiveness analysis was conducted including 85 patients, as advised by the Data Safety Monitoring Board. The study population was randomly assigned to standard care (SC) alone and standard care plus additional HBOT (60 each) using a computer-randomization software program (ALEA v. 2.2, NKI-AVL, Netherlands). All patients received open/endovascular revascularization if applicable, and then received standard care along with local wound management or HBOT, as required.