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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Botulinum Toxins

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