Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease (BETOX)
Buerger Disease, Raynaud Syndrome
About this trial
This is an interventional treatment trial for Buerger Disease focused on measuring botulinum toxin A, botox, feasibility, raynaud, buerger, tolerance
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years patient with Buerger's disease according to Olin criteria (ref) 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). Ability to attend study visits Ability to complete daily study agenda Ability to give free and informed consent Membership of a Social Security scheme Exclusion Criteria: History of myasthenia gravis or Eaton-Lambert syndrome History of inflammatory myositis for less than 2 years or pre-existing motor neuron disease or superior limb neuropathy. Known allergy to botulinum toxin or cream lidocaine, albumin or inhaled nitrous oxide/oxygen. Progressive infection of one hand or foot Aminoglycoside treatment Pregnant or nursing women History of vascular surgery of surgical sympathectomy of upper or lower limb Revascularization procedure considered within 3 months of inclusion Risk of major amputation within 3 months of inclusion Iloprost expected within one month of study treatment Hyperbaric chamber sessions scheduled within one month of study treatment Life expectancy less than 6 months Contraindication to one or more of the following products: BOTOX 100 UNITS ALLERGAN, LIDOCAINE/PRILOCAINE 5%, cream or NITROUS OXIDE MEDICINAL Patients treated by class III anti arhythmic drugs for example amiodarone 15 ) Patient with guardians, curators, or protection of justice
Sites / Locations
Arms of the Study
Arm 1
Experimental
drug administration
Botox Injection