Buerger DiseasePhase 3BETOXNCT05698979
Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
A Phase 3 study testing BOTOX INJECTION in people with Buerger Disease and Raynaud Syndrome, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The main objective is to assess the feasibility of treatment by injecting botulinum toxin A into the hand or foot of patients with signs of critical ischemia secondary to Buerger's disease. The injection of botulinum toxin A is carried out at the end of a single session during an hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Buerger Disease, Raynaud Syndrome
- What is being tested?
- BOTOX INJECTION
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2027to Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- patient with Buerger's disease according to Olin criteria (ref)
- with digital ischemia with critical upper or lower limb ischemia criteria defined as Upper limb: pain and/or trophic disorders for at least 15 days AND digital pressure less than 50 mmHg Or TCPO2 30 mmHg) Or/and Lower limb: pain and/or trophic disorders for at least 15 days AND ankle pressure less than 50 mmHg (70 mmHg if diabetes), or 30 mmHg at the toe (50 mmHg if diabetes) or TCPO2 30 mmHg).
- Ability to attend study visits
- Ability to complete daily study agenda
- Ability to give free and informed consent
- Membership of a Social Security scheme
Who cannot join
- History of myasthenia gravis or Eaton-Lambert syndrome
- History of inflammatory myositis for less than 2 years or pre-existing motor neuron disease or superior limb neuropathy.
- Known allergy to botulinum toxin or cream lidocaine, albumin or inhaled nitrous oxide/oxygen.
- Progressive infection of one hand or foot
- Aminoglycoside treatment
- Pregnant or nursing women
Show all 14Show fewer
- History of vascular surgery of surgical sympathectomy of upper or lower limb
- Revascularization procedure considered within 3 months of inclusion
- Risk of major amputation within 3 months of inclusion
- Iloprost expected within one month of study treatment
- Hyperbaric chamber sessions scheduled within one month of study treatment
- Life expectancy less than 6 months
- Contraindication to one or more of the following products: BOTOX 100 UNITS ALLERGAN, LIDOCAINE/PRILOCAINE 5%, cream or NITROUS OXIDE MEDICINAL
- Patients treated by class III anti arhythmic drugs for example amiodarone 15 ) Patient with guardians, curators, or protection of justice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University Hospital Toulouse
Toulouse, CHU de Toulouse, 31059
Julie MALLOIZEL DELAUNAY, MD
TOMASIK, tomasik.a@chu-toulouse.fr
About this study
The main objective is to assess the feasibility of treatment by injecting botulinum toxin A into the hand or foot of patients with signs of critical ischemia secondary to Buerger's disease. The injection of botulinum toxin A is carried out at the end of a single session during an hospitalization. Furthermore, tolerance and effects on the disease are evaluated at 1, 3 and 6 months post injections.
Read the detailed description
Buerger's disease or obliterate thromboangiitis(TAO) is a rare disease. It is an inflammatory, segmental and occlusive disease affecting small and medium caliber arteries and veins in the extremities of the limbs. It mainly affects young men, who traditionally smoke, before the age of 45. There is currently no specific treatment for Buerger's disease. Surgical treatment is rarely feasible, due to distal and diffuse damage. Several studies have evaluated the perivascular injection of botulinum toxin type A (BTX) in patients with severe Raynaud syndromes linked to scleroderma, with promising results.
Studies with BTX have shown reduced pain, improved tissue perfusion with laser doppler, and healing of digital ulcers.
The patients are treated with a single session with botulinum toxin A injections during an hospital visit, and the judgmental criteria are assessed at 1, 3 and 6 months post injections.
The injections are made at 4 injection points at the palmar or distal plantar fold, at the level of the neurovascular beams, 2h after topical anesthesia by lidocaine cream under occlusion, associated or not with nitrous oxide inhaled at the time of the injections (BOTOX® 100 U, botulinum toxin A injections in each hand or foot, for a final dose of 50 U (1 ml) per extremity).
- Conditions
- Buerger Disease, Raynaud Syndrome
- Being tested
- BOTOX INJECTION
- Keywords
- botulinum toxin A, botox, feasibility, raynaud, buerger, tolerance
- Medical subject headings
- Thromboangiitis Obliterans, Raynaud Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOTOX INJECTIONDrug
Also called botulinum toxin
The patient will be treated with a single session with botulinum toxin A injections at the hospital, and the judgmental criteria will be assessed at 1, 3 and 6 months post injections.
The injections will be made in 4 injection points at the palmar or distal plantar fold, at the level of the neurovascular beams, 2h after topical anesthesia by lidocaine cream under occlusion, associated or not with nitrous oxide inhaled at the time of the injections (BOTOX® 100 U).
In the event of multiple lesions, a single limb is injected based on clinical severity (ulcer, gangrene) and ischemia parameters (lowest TCPO2).
| Study group | Role | What they receive |
|---|---|---|
| drug administration | Experimental | Botox Injection Receives: Drug: BOTOX INJECTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility in Number of patients
The feasibility criterion corresponds to the number of patients who actually received the planned injections within the defined time limits, among the patients who should have received the injection according to the criteria of the protocol.
Measured: through study completion, an average of 18 months
Secondary outcomes (4)
tolerance of participants
collection of temporary low grade adverse events (hematoma, erythema, ecchymosis at the injection site, pain, before/after and during injection)
Measured: during injection
tolerance of participants
collection of temporary low grade adverse events (hematoma, erythema, ecchymosis at the injection site, pain, before/after and during injection)
Measured: 2 hours after injection
tolerance during injection
collection of temporary high grade adverse events (muscle weakness, temporary or prolonged headache, general muscle weakness or muscle group at distance from injection site, difficulty swallowing, dyspnea, immediate allergic reaction to injections)
Measured: during injection
tolerance after injection
collection of temporary high grade adverse events (muscle weakness, temporary or prolonged headache, general muscle weakness or muscle group at distance from injection site, difficulty swallowing, dyspnea, immediate allergic reaction to injections)
Measured: 2 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Jan 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Buerger DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Malloizel-Delaunay, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698979
- Sponsor's protocol ID
- RC31/20/0445
- Acronym
- BETOX
- Status last verified
- Jul 2026
- First submitted
- 5 Jan 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
- ClinicalTrials.gov ID
- NCT05698979
- Acronym / sponsor ID
- BETOX / RC31/20/0445
- Conditions
- Buerger Disease, Raynaud Syndrome
- Keywords
- botulinum toxin A, botox, feasibility, raynaud, buerger, tolerance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 26 Jan 2023 (actual)
- 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.
The main objective is to assess the feasibility of treatment by injecting botulinum toxin A into the hand or foot of patients with signs of critical ischemia secondary to Buerger's disease. The injection of botulinum toxin A is carried out at the end of a single session during an hospitalization. Furthermore, tolerance and effects on the disease are evaluated at 1, 3 and 6 months post injections.
Detailed description
Buerger's disease or obliterate thromboangiitis(TAO) is a rare disease. It is an inflammatory, segmental and occlusive disease affecting small and medium caliber arteries and veins in the extremities of the limbs. It mainly affects young men, who traditionally smoke, before the age of 45. There is currently no specific treatment for Buerger's disease. Surgical treatment is rarely feasible, due to distal and diffuse damage. Several studies have evaluated the perivascular injection of botulinum toxin type A (BTX) in patients with severe Raynaud syndromes linked to scleroderma, with promising results.
Studies with BTX have shown reduced pain, improved tissue perfusion with laser doppler, and healing of digital ulcers.
The patients are treated with a single session with botulinum toxin A injections during an hospital visit, and the judgmental criteria are assessed at 1, 3 and 6 months post injections.
The injections are made at 4 injection points at the palmar or distal plantar fold, at the level of the neurovascular beams, 2h after topical anesthesia by lidocaine cream under occlusion, associated or not with nitrous oxide inhaled at the time of the injections (BOTOX® 100 U, botulinum toxin A injections in each hand or foot, for a final dose of 50 U (1 ml) per extremity).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| drug administration | Experimental | Drug: BOTOX INJECTIONBotox Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- patient with Buerger's disease according to Olin criteria (ref)
- with digital ischemia with critical upper or lower limb ischemia criteria defined as Upper limb: pain and/or trophic disorders for at least 15 days AND digital pressure less than 50 mmHg Or TCPO2 30 mmHg) Or/and Lower limb: pain and/or trophic disorders for at least 15 days AND ankle pressure less than 50 mmHg (70 mmHg if diabetes), or 30 mmHg at the toe (50 mmHg if diabetes) or TCPO2 30 mmHg).
- Ability to attend study visits
- Ability to complete daily study agenda
Key exclusion criteria (14 listed)
- History of myasthenia gravis or Eaton-Lambert syndrome
- History of inflammatory myositis for less than 2 years or pre-existing motor neuron disease or superior limb neuropathy.
- Known allergy to botulinum toxin or cream lidocaine, albumin or inhaled nitrous oxide/oxygen.
- Progressive infection of one hand or foot
- Aminoglycoside treatment
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 |
|---|---|---|
| BOTOX INJECTIONAlso: botulinum toxinThe patient will be treated with a single session with botulinum toxin A injections at the hospital, and the judgmental criteria will be assessed at 1, 3 and 6 months post injections. The injections will be made in 4 injection points at the palmar or distal plantar fold, at the level of the neurovascular beams, 2h after topical anesthesia by lidocaine cream under occlusion, associated or not with nitrous oxide inhaled at the time of the injections (BOTOX® 100 U). In the event of multiple lesions, a single limb is injected based on clinical severity (ulcer, gangrene) and ischemia parameters (lowest TCPO2). | Drug | drug administration |
Primary outcome
Feasibility in Number of patients
Time frame: through study completion, an average of 18 months
The feasibility criterion corresponds to the number of patients who actually received the planned injections within the defined time limits, among the patients who should have received the injection according to the criteria of the protocol.
4 secondary outcomes
tolerance of participants
Time frame: during injection
tolerance of participants
Time frame: 2 hours after injection
tolerance during injection
Time frame: during injection
tolerance after injection
Time frame: 2 hours after injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Buerger Disease
Active, not recruiting
Comparative Effectiveness of Nursing Interventions: Using Buerger-Allen Exercises Versus Mechanical Compression Therapy on Lower Limb Perfusion and Peripheral Neuropathy Among Patients Undergoing Chemotherapy.
Polyneuropathies, Regional Blood Flow
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.
Julie Malloizel-Delaunay, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BOTOX INJECTION in people with Buerger Disease and Raynaud Syndrome, run by University Hospital, Toulouse at 1 site in France.
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 7 inclusion and 14 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: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Malloizel-Delaunay, MD (05 61 32 30 33, malloizel-delaunay.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility in Number of patients (time frame: through study completion, an average of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2026.