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

NCT ID: NCT05698979

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-02-28

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

drug administration

Botox Injection

Group Type: EXPERIMENTAL

BOTOX INJECTION

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

Other Intervention Names

botulinum toxin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Malloizel-Delaunay, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Central Contacts

Julie Malloizel-Delaunay, MD

Role: CONTACT

malloizel-delaunay.j@chu-toulouse.fr

05 61 32 30 33

Related Links

https://www.has-sante.fr/upload/docs/application/pdf/AOMI_recos.pdf

Related Info

Other Identifiers

RC31/20/0445

Identifier Type: -

Identifier Source: org_study_id