Thromboangiitis ObliteransNCT01447550
Treatment of Thromboangiitis Obliterans (Buerguer's Disease) With Bosentan
An observational study of Thromboangiitis Obliterans, run by Hospital Universitario Getafe at 2 sites in Spain.
Trial summary
This study assessed the effectiveness and safety of bosentan when administered to thromboangiitis obliterans (Buerger's disease)patients. A clinical pilot study was designed,included in which patients with ulcer and/or pain at rest were treated with bosentan p.o at a dose of 62,5 mg twice daily during the first month… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thromboangiitis Obliterans
- What is being tested?
- Bosentan
- Type of treatment
- Pill or oral medicine
- How many people
- 12 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2009to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from Buerger's disease
Who may be able to join
- Critical ischemia in any extremity, causing pain at rest or non-healing ischemic ulcers, present for at least four weeks with no evidence of improvement in response to conventional treatment.
Who cannot join
- Being candidates for surgical or endovascular revascularisation of the extremity studied.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario de Getafe
Getafe, Getafe, 28901
Hospital Universitario Getafe
Getafe, Madrid, 28905
About this study
Official title: Treatment of Thromboangiitis Obliterans (Buerger's Disease) With Bosentan
This study assessed the effectiveness and safety of bosentan when administered to thromboangiitis obliterans (Buerger's disease)patients. A clinical pilot study was designed,included in which patients with ulcer and/or pain at rest were treated with bosentan p.o at a dose of 62,5 mg twice daily during the first month, which each thereafter uptitrated to 125 mg twice daily. Study endpoints were clinical improvement rate, major or minor amputation rate, hemodynamic changes, changes in endothelial function and angiographic changes.
12 patients were included were current smokers. With bosentan treatment, no new ischemic lesions were observed in all but one patient. Overall, clinical improvement was observed in 12 of the 13 extremities (92%). Only two of 13 extremities underwent amputation after bosentan treatment. As assessed by digital arteriography with subtraction or angio-magnetic resonance image an increase of distal flow was observed in 10 out of the 12 patients. All patients experienced a statistically significant improvement in their BAFMD values (means:1.8 at baseline;6.6 at the end of the treatment;12.7 three months after the end of the treatment;p<0.01). In conclusion: Bosentan treatment may result in an improvement of clinical, angiographic, hemodynamic and endothelial function outcome. Bosentan deserves further investigation in the management TAO patients.
- Conditions
- Thromboangiitis Obliterans
- Being tested
- Bosentan
- Keywords
- Bosentan, Buerguer disease
- Medical subject headings
- Thromboangiitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosentanDrug
Bosentan therapy consisted of a month's treatment with 62.5 mg bid orally administered. Dose doubled to 125 mg bid after the first month. The full-dose regimen (125 mg/12h) was maintained for the following months or until total healing fo the ulcers.
| Study group | Role | What they receive |
|---|---|---|
| Bosentan | Bosentan Receives: Drug: Bosentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement rate
Clinical improvement rate (absence of new throphic lesions, ulcer healing process, pain relief, complete absence of pain), major of minor amputation rate
Measured: 4-6 months
Clinical improvement rate
Clinical improvement rate (abscence of new throphic lesions, ulcer healing process, pain relief, complete absence of pain), major of minor amputation rate
Measured: 4-6 months
Clinical improvement rate
Clinical improvement rate (absence of new throphic lesions, ulcer healing process, pain relief, complete absense of pain), major of minor amputation rate
Measured: 4-6 months
Secondary outcomes (1)
haemodynamics, endothelial function and angiographic changes
Hemodynamic changes as measured by means of ABI, changes in endothelial funtion as measured by means of the brachial artery flow-mediated dilation test (BAFMD) and angiographic changes as measured by means of arteriography with digital substraction or an angio-magnetic resonance image (MRI).
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thromboangiitis ObliteransStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Getafe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquin de Haro, M.D., Hospital Universitario Getafe
- Investigators
- Joaquin De Haro, MD,PhD, Principal investigator, Hospital Universitario de Getafe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447550
- Sponsor's protocol ID
- Buerger-Bosentan
- Status last verified
- Aug 2016
- First submitted
- 5 Oct 2011
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
De Haro J, Bleda S, Acin F. An open-label study on long-term outcomes of bosentan for treating ulcers in thromboangiitis obliterans (Buerger's disease). Int J Cardiol. 2014 Dec 15;177(2):529-31. doi: 10.1016/j.ijcard.2014.08.107. Epub 2014 Aug 23. No abstract available.
PubMed 25217217De Haro J, Acin F, Bleda S, Varela C, Esparza L. Treatment of thromboangiitis obliterans (Buerger's disease) with bosentan. BMC Cardiovasc Disord. 2012 Feb 14;12:5. doi: 10.1186/1471-2261-12-5.
PubMed 22333218
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Thromboangiitis Obliterans (Buerger's Disease) With Bosentan
- ClinicalTrials.gov ID
- NCT01447550
- Acronym / sponsor ID
- Buerger-Bosentan
- Conditions
- Thromboangiitis Obliterans
- Keywords
- Bosentan, Buerguer disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospital Universitario GetafeUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assessed the effectiveness and safety of bosentan when administered to thromboangiitis obliterans (Buerger's disease)patients. A clinical pilot study was designed,included in which patients with ulcer and/or pain at rest were treated with bosentan p.o at a dose of 62,5 mg twice daily during the first month, which each thereafter uptitrated to 125 mg twice daily. Study endpoints were clinical improvement rate, major or minor amputation rate, hemodynamic changes, changes in endothelial function and angiographic changes.
12 patients were included were current smokers. With bosentan treatment, no new ischemic lesions were observed in all but one patient. Overall, clinical improvement was observed in 12 of the 13 extremities (92%). Only two of 13 extremities underwent amputation after bosentan treatment. As assessed by digital arteriography with subtraction or angio-magnetic resonance image an increase of distal flow was observed in 10 out of the 12 patients. All patients experienced a statistically significant improvement in their BAFMD values (means:1.8 at baseline;6.6 at the end of the treatment;12.7 three months after the end of the treatment;p<0.01). In conclusion: Bosentan treatment may result in an improvement of clinical, angiographic, hemodynamic and endothelial function outcome. Bosentan deserves further investigation in the management TAO patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bosentan | – | Drug: BosentanBosentan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from Buerger's disease
Key inclusion criteria (1 listed)
- Critical ischemia in any extremity, causing pain at rest or non-healing ischemic ulcers, present for at least four weeks with no evidence of improvement in response to conventional treatment.
Key exclusion criteria (1 listed)
- Being candidates for surgical or endovascular revascularisation of the extremity studied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BosentanBosentan therapy consisted of a month's treatment with 62.5 mg bid orally administered. Dose doubled to 125 mg bid after the first month. The full-dose regimen (125 mg/12h) was maintained for the following months or until total healing fo the ulcers. | Drug | Bosentan |
Primary outcome
Clinical improvement rate
Time frame: 4-6 months
Clinical improvement rate (absence of new throphic lesions, ulcer healing process, pain relief, complete absence of pain), major of minor amputation rate
Clinical improvement rate
Time frame: 4-6 months
Clinical improvement rate (abscence of new throphic lesions, ulcer healing process, pain relief, complete absence of pain), major of minor amputation rate
Clinical improvement rate
Time frame: 4-6 months
Clinical improvement rate (absence of new throphic lesions, ulcer healing process, pain relief, complete absense of pain), major of minor amputation rate
1 secondary outcome
haemodynamics, endothelial function and angiographic changes
Time frame: 4-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Derived from this study: PubMed 25217217De Haro J, Bleda S, Acin F. An open-label study on long-term outcomes of bosentan for treating ulcers in thromboangiitis obliterans (Buerger's disease). Int J Cardiol. 2014 Dec 15;177(2):529-31. doi: 10.1016/j.ijcard.2014.08.107. Epub 2014 Aug 23. No abstract available.
- Derived from this study: PubMed 22333218De Haro J, Acin F, Bleda S, Varela C, Esparza L. Treatment of thromboangiitis obliterans (Buerger's disease) with bosentan. BMC Cardiovasc Disord. 2012 Feb 14;12:5. doi: 10.1186/1471-2261-12-5.
Related trials for Thromboangiitis Obliterans
Not yet recruitingPhase 3
Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
Buerger Disease, Raynaud Syndrome
RecruitingPhase 1
A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smokers
Thromboangiitis Obliterans (Buerger's Disease)
RecruitingPhase 4
Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease
Critical Limb Ischemia, Buerger's Disease
Enrolling by invitationObservational study
Follow-up Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-L)
Peripheral Arterial Disease(PAD), Arterial Occlusive Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joaquin De Haro, MD,PhD principal investigator
Hospital Universitario de Getafe
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboangiitis Obliterans, run by Hospital Universitario Getafe at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement rate (time frame: 4-6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01447550, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.