Does Applying More Oxygen Cure Lower Extremity Sores?
- Conditions
- Ischemic diabetic ulcerspoorly perfused wounds100470431004341310003216
- Registration Number
- NL-OMON41563
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 275
1. Type I or II diabetes
2. Wagner 2, 3 or 4 lower extremity ulcer(s), present for at least 4 weeks
3. Leg ischemia defined as: highest ankle systolic blood pressure < 70 mmHg or toe systolic pressure < 50 mmHg or TcpO2 < 40 mmHg
4. Complete assessment of peripheral arterial lesions from the aorta to the tibial arteries with duplex ultrasonography, magnetic resonance angiography, computed tomography angiography or intra-arterial digital subtraction angiography of the ipsilateral leg
5. Age * 18 years
6. Written informed consent
1. Previous major amputation of the leg with the index ulcer
2. COPD GOLD IV
3. Current treatment with chemotherapy, immunosuppressive drugs or systemic corticosteroids (daily 10mg or more)
4. Eind-stadium nierfalen, waarvoor dialyse nodig is
5. Metastatized malignancy.
6. Left ventricular failure with EF <20% of externe pacemaker
7. Pregnancy
8.Insufficient proficiency of Dutch language, or unability to complete the Dutch questionnaires, or not compos mentis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints are freedom of major (above ankle) amputations after 12<br /><br>months, and achievement of, and time to, complete wound healing. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are pain scores, freedom of minor amputations after 12<br /><br>months, TcPO2, quality of life, costs, need for vascular interventions and<br /><br>safety. Moreover, markers of wound healing, coagulation and oxidative stress<br /><br>will be assessed to investigate the possible working mechanisms of HBOT.</p><br>