Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently?

Phase 4

Recruiting

Conditions: 10040795
10003216
Ischemic diabetic foot ulcer
wound on the foot with vascular insufficiency

Registration Number: NL-OMON52592

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

1. Type I or II diabetes
2. Meggitt-Wagner 3 or 4 lower extremity ulcer(s), present for at least 4 weeks
or after a minor amputation because of a previously existing ischemic DFU. In
case more than one ulcer is present, the largest will be observed as target
ulcer
3. Leg ischemia, 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. Adults
6. 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
<p>Major amputation rate (above ankle) and (major)l after 3 years of follow-up</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Amputation-free survival<br />- Health-related quality of life<br />- Complete wound healing<br />- Pain scores<br />- Need for additional (vascular) interventions<br />- Cost-effectiveness and budget impact<br />- Mortality<br />- Patients perception of improvement<br />- TcpO2 before, during and after HBOT</p>