Hyperbaric Oxygen Therapy as adjunctive treatment of chronic diabetic foot ulcers

Abstract: Chronic diabetic foot ulcers are a source of major concern for both patients and health care systems. Oxygen deficiency plays a major role in the pathogenesis of these ulcers. Hyperbaric oxygen therapy (HBOT) has been proposed as a medical treatment for diabetic foot ulcers, but the clinical utility has not been established. Hyperbaric Oxygen in Diabetic patients with chronic Foot Ulcer (HODFU) study is a prospective, randomized, placebo-controlled, double-blinded study, evaluating the effect of HBOT on ulcer healing in diabetic patients with chronic foot ulcers. Ninety four patients were included, representing 74% of all patients fulfilling the medical inclusion criteria during the inclusion period. Adjunctive HBOT significantly improved foot ulcer healing at 9- and 12-months follow-ups as compared to placebo. Numbers-needed to treat to avert non-healing of a chronic foot ulcer was 3.1. Treatment was well-tolerated and frequencies of adverse events were low. TcPO2, but not toe-blood pressure or ankle-brachial index, was identified as prognostic marker for ulcer healing after HBOT. At one-year follow-up HBOT was associated with improved health related quality of life. Patients perceived HBOT as unproblematic but time-consuming. Evaluation of these patients cardiac function indicates that a chronic diabetic foot ulcer should be regarded as a marker of cardiac disease. Thus, pharmacological cardiovascular prevention ought to be considered in all patients with a chronic diabetic foot ulcer. In conclusion, this study supports the concept that adjunctive treatment with HBOT enhances foot ulcer healing in selected patients with diabetes.