Study on the effect of Bosentan on trophic skin lesions in diabetic fOOT Syndrome (BOOTS)
| ISRCTN | ISRCTN51795022 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51795022 |
| Secondary identifying numbers | BOOTS |
- Submission date
- 09/01/2012
- Registration date
- 20/02/2012
- Last edited
- 31/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Diabetes may trigger the development of a diabetic foot (open wounds on the foot). These wounds develop due to pathologically modified blood vessels with reduced blood circulation in the foot. They heal badly, are prone to infections and may require amputation of the foot. Therapies focus on surgical re-opening of the big blood vessels or on the application of vessel-dilating drugs. Bosentan is such a vessel-dilating drug. This study looks at how well bosentan works in improving the circulation of the foot and healing of the wounds.
Who can participate?
Male and female patients older than 18 years with a diabetic foot may participate.
What does the study involve?
All participants will receive bosentan for 4 months. Oxygen and blood supply of the skin, toe blood pressure, and size and pain of the wounds are measured 2 weeks, 1 and 4 months thereafter.
What are the possible benefits and risks of participating?
If bosentan works, circulation will improve and therefore the wounds may heal. The most frequent side effects of bosentan are headache, flush, leg swellings and anemia.
Where is the study run from?
University Hospital of Zürich (Switzerland).
When is the study starting and how long is it expected to run for?
The study started in January 2012 and planned to end patient enrolment in February 2013.
Who is funding the study?
This study is designed and organized by the University Hospital of Zürich, who are receiving the drug and financial support from Actelion, the licence owner of Tracleer®, which is the marketed product of bosentan. All study-related procedures and costs are covered by the University Hospital of Zürich.
Who is the main contact?
Dr Thomas Meier at the Clinic for Angiology
Contact information
Scientific
Clinic for Angiology
University Hospital Zürich
Rämistrasse 100
Zürich
CH-8091
Switzerland
Study information
| Study design | Monocentric non-comparative open-label pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Open-label pilot study on the effect of Bosentan on trophic skin lesions in the diabetic fOOT Syndrome |
| Study acronym | BOOTS |
| Study objectives | Bosentan improves peripheral tissue perfusion in diabetic patients with foot ulcers |
| Ethics approval(s) | Cantonal Ethics Committee Zürich, 24/10/2011, ref: 2011-0216 |
| Health condition(s) or problem(s) studied | Diabetic foot syndrome |
| Intervention | All enrolled patients will receive 62.5 mg bosentan (Tracleer®) twice a day (BID) for 4 weeks followed by 125 mg bosentan BID for 3 months. Total duration of treatment and follow up is 4 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bosentan |
| Primary outcome measure | 1. Transcutaneous oxygen tension 2. Reactive hyperemia Measured at 2 weeks, 1 month and 4 months |
| Secondary outcome measures | 1. Size and number of the ischemic skin lesions 2. Toe blood pressure 3. Local pain Measured at 2 weeks, 1 month and 4 months |
| Overall study start date | 20/01/2012 |
| Completion date | 30/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 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) |
| Key exclusion criteria | 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 |
| Date of first enrolment | 20/01/2012 |
| Date of final enrolment | 30/05/2013 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
CH-8091
Switzerland
Sponsor information
Hospital/treatment centre
Rämistrasse 100
Zürich
CH-8091
Switzerland
| Website | http://www.en.usz.ch/ |
|---|---|
"ROR" |
https://ror.org/01462r250 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
