Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

Conditions: Diabetic foot ulcers, diabetes, peripheral arterial occlusive disease

Registration Number: NL-OMON27651

Lead Sponsor: Amsterdam University Medical Centers, location AMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 544

Inclusion Criteria

1. Type I or II diabetes
2. One or more deep and clinically infected lower extremity ulcers, classified as Meggit-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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major amputation rate (above ankle) and after 12 months of follow-up

Secondary Outcome Measures

Name	Time	Method
Major amputation-free survival<br>o Health-related quality of life scores (EQ-5D-5L, SF-12, Vascuqol-6)<br>o Complete wound healing<br>o Pain score (VAS)<br>o Freedom from minor amputation (below ankle)<br>o Time to reach complete wound healing<br>o Costs related to HBOT and conventional therapy during follow-up period<br>o Patients’ out of pocket expenses related to disease or treatment (travel expenses etc.)<br>o Mortality<br>o Patients’ perception of improvement (through one anchor question)<br>o Forefoot TcpO2 before, during and after (HBOT) treatment (if equipment is available)