Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/01/2012
Date assigned
20/02/2012
Last edited
31/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thomas Meier

ORCID ID

Contact details

Clinic for Angiology
University Hospital Zürich
Rämistrasse 100
Zürich
CH-8091
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BOOTS

Study information

Scientific title

Open-label pilot study on the effect of Bosentan on trophic skin lesions in the diabetic fOOT Syndrome

Acronym

BOOTS

Study hypothesis

Bosentan improves peripheral tissue perfusion in diabetic patients with foot ulcers

Ethics approval

Cantonal Ethics Committee Zürich, 24/10/2011, ref: 2011-0216

Study design

Monocentric non-comparative open-label pilot study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Bosentan

Primary outcome measures

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 trial start date

20/01/2012

Overall trial end date

30/05/2013

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

20/01/2012

Recruitment end date

30/05/2013

Locations

Countries of recruitment

Switzerland

Trial participating centre

Clinic for Angiology
Zürich
CH-8091
Switzerland

Sponsor information

Organisation

University Hospital Zürich (Switzerland)

Sponsor details

Rämistrasse 100
Zürich
CH-8091
Switzerland

Sponsor type

Hospital/treatment centre

Website

http://www.en.usz.ch/

Funders

Funder type

Industry

Funder name

Actelion Pharma Schweiz (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes