Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

• Status: Recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this multicenter, multi-national, multi-arm, multi-stage, randomized controlled trial, is to determine the added benefit of hyperbaric oxygen treatment (HBOT) in patients with diabetic foot ulcers and peripheral vascular disease. The main question is:

• What is the difference is the major amputation rate between the study arms?

Participants will be randomized to 20, 30 or 40 sessions of HBOT or a control group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development

Criteria

Inclusion Criteria:

1. Type I or II diabetes

2. 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

3. Leg ischaemia, characterized by a highest ankle systolic blood pressure < 70 mmHg, or a toe systolic pressure < 50 mmHg or a TcpO2 < 40 mmHg

4. 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

5. Patients have to be discussed in, and included after a multidisciplinary consultation.

6. Adults

7. Written informed consent

Exclusion Criteria:

1. Chronic Obstructive Pulmonary Disease (COPD) GOLD IV

2. Treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids within last 3 months, as this interferes with normal wound healing

3. End-stage renal disease requiring dialysis

4. Metastasized malignancy

5. Left ventricular failure with ejection fraction (EF) <20% or external pacemaker

6. Recent thoracic surgery or middle ear surgery

7. Severe epilepsy

8. Uncontrollable high fever

9. Pregnancy

10. Insufficient proficiency of local language/English, or inability to complete the questionnaires