Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently? (DIONYSIUS)
Peripheral Vascular Disease, Diabetic Foot Ulcer, Amputation
About this trial
This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring Diabetic Foot Ulcer, Hyperbaric Oxygen, Peripheral Vascular Disease, HBOT, DFU, Major amputation, Diabetes, Ischemia
Eligibility Criteria
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
Sites / Locations
- Amsterdam UMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Experimental
Experimental
Experimental
Control
HBOT 20
HBOT 30
HBOT 40
Control group
Patients receiving 20 sessions of concurrent Hyperbaric oxygen treatment
Patients receiving 30 sessions of concurrent Hyperbaric oxygen treatment
Patients receiving at least 40 sessions of concurrent Hyperbaric oxygen treatment