NCT05698979

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2023-01-26
• Last updated: 2024-10-30