Study on the effect of Bosentan on trophic skin lesions in diabetic fOOT Syndrome (BOOTS)
- Conditions
- Diabetic foot syndromeNutritional, Metabolic, EndocrineInsulin-dependent diabetes mellitus
- Registration Number
- ISRCTN51795022
- Lead Sponsor
- niversity Hospital Zürich (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
1. Provided written informed consent
2. Male and female patients aged > 18 years
3. With diabetic foot syndrome (irrespective of catheter technical or surgical revascularisation plans and irrespective of the presence of any infection)
1. Trophic skin lesions due to other diseases than diabetes
2. Planned amputation within the following 4 months
3. Revascularisation within 4 weeks prior to inclusion
4. Systolic BP < 85 mm Hg
5. Hb <75% of the lower limit of normal
6. Severe malabsorption or any severe organ failure or any life-threatening state
7. Contraindications to the use of bosentan
8. Previous treatment with bosentan
9. Treatment with botulinus toxin, prostanoids, sildenafil or any other experimental treatment
10. Body weight< 40 kg
11. Patients unable to provide informed consent and comply with the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Transcutaneous oxygen tension <br>2. Reactive hyperemia <br><br>Measured at 2 weeks, 1 month and 4 months
- Secondary Outcome Measures
Name Time Method 1. Size and number of the ischemic skin lesions<br>2. Toe blood pressure<br>3. Local pain <br><br>Measured at 2 weeks, 1 month and 4 months