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

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Jan 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of botulinum toxin A (commonly known as Botox) as a potential treatment for patients with Buerger's disease, a condition that affects blood flow in the hands and feet. The goal is to see if injecting this toxin into the affected areas can help improve blood circulation and alleviate symptoms like pain and tissue damage. The trial will involve a single injection during a hospital visit, and researchers will monitor how well the treatment works and how patients tolerate it over the next six months.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with Buerger's disease, experiencing severe blood flow problems in their hands or feet. They should be able to attend follow-up appointments and give their consent to participate. Unfortunately, not everyone can join; for example, those with certain neurological conditions or recent major surgeries won’t qualify. Participants can expect to receive the injection and then have regular check-ins to assess their progress and any side effects. This trial is important as it could lead to new treatment options for those suffering from this challenging condition.

Gender

ALL

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