DIONYSIUS trial: "Does increasing oxygen nurture your symptomatic ischaemic ulcer sufficiently?" Study protocol for an international multicentre randomised trial.

Introduction: Diabetic foot ulcers (DFUs) are a major complication of diabetes and often associated with peripheral arterial occlusive disease. Current available evidence shows hyperbaric oxygen therapy (HBOT) can reduce the risk of major amputation, but clinicians remain sceptical about the (cost-)effectiveness and feasibility of HBOT for ischaemic DFUs in clinical practice. Therefore, vascular surgeons and HBOT physicians worldwide feel a strong need for a sufficiently powered clinical trial to determine whether and how many HBOT sessions may be a (cost-)effective adjunctive treatment to ischaemic DFUs.