Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently? (DIONYSIUS)

Inclusion Criteria: Type I or II diabetes One or more deep and clinically infected lower extremity ulcers, classified as Meggitt-Wagner class 3 or 4, Texas class 2C, 3C, 2D or 3D, or WIfI class W>1, I>1 and fI>0), present for at least 4 weeks or after a minor amputation because of a previously existing ischaemic DFU on a toe or forefoot. In case more than one ulcer is present, the largest will be observed as target ulcer Leg ischaemia, characterized by a highest ankle systolic blood pressure < 70 mmHg, or a toe systolic pressure < 50 mmHg or a TcpO2 < 40 mmHg Complete assessment of peripheral arterial lesions from the aorta to the pedal arteries with duplex ultrasonography, magnetic resonance angiography, computed tomography angiography and/or intraarterial digital subtraction angiography of the ipsilateral leg Patients have to be discussed in, and included after a multidisciplinary consultation. Adults Written informed consent Exclusion Criteria: Chronic Obstructive Pulmonary Disease (COPD) GOLD IV Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within last 3 months, as this interferes with normal wound healing End-stage renal disease requiring dialysis Metastasized malignancy Left ventricular failure with ejection fraction (EF) <20% or external pacemaker Recent thoracic surgery or middle ear surgery Severe epilepsy Uncontrollable high fever Pregnancy Insufficient proficiency of local language/English, or inability to complete the questionnaires