Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease

Raynaud Syndrome Clinical Trial

— BETOX  

Official title:

Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05698979
• Other study ID #: RC31/20/0445
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 30, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Julie Malloizel-Delaunay, MD
• Phone: 05 61 32 30 33
• Email: malloizel-delaunay.j[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Furthermore, tolerance and effects on the disease are evaluated at 1, 3 and 6 months post injections.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. patient with Buerger's disease according to Olin criteria (ref)

3. 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).

4. Ability to attend study visits

5. Ability to complete daily study agenda

6. Ability to give free and informed consent

7. Membership of a Social Security scheme

Exclusion Criteria:

1. History of myasthenia gravis or Eaton-Lambert syndrome

2. History of inflammatory myositis for less than 2 years or pre-existing motor neuron disease or superior limb neuropathy.

3. Known allergy to botulinum toxin or cream lidocaine, albumin or inhaled nitrous oxide/oxygen.

4. Progressive infection of one hand or foot

5. Aminoglycoside treatment

6. Pregnant or nursing women

7. History of vascular surgery of surgical sympathectomy of upper or lower limb

8. Revascularization procedure considered within 3 months of inclusion

9. Risk of major amputation within 3 months of inclusion

10. Iloprost expected within one month of study treatment

11. Hyperbaric chamber sessions scheduled within one month of study treatment

12. Life expectancy less than 6 months

13. Contraindication to one or more of the following products: BOTOX 100 UNITS ALLERGAN, LIDOCAINE/PRILOCAINE 5%, cream or NITROUS OXIDE MEDICINAL

14. Patients treated by class III anti arhythmic drugs for example amiodarone 15 ) Patient with guardians, curators, or protection of justice

Related Conditions & MeSH terms

• Buerger Disease
• Raynaud Disease
• Raynaud Syndrome
• Thromboangiitis Obliterans

Intervention

Drug:
• BOTOX INJECTION
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 18 months
Secondary	tolerance of participants	collection of temporary low grade adverse events (hematoma, erythema, ecchymosis at the injection site, pain, before/after and during injection)	during injection
Secondary	tolerance of participants	collection of temporary low grade adverse events (hematoma, erythema, ecchymosis at the injection site, pain, before/after and during injection)	2 hours after injection
Secondary	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)	during injection
Secondary	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)	2 hours after injection

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