[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492963":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":30,"responsibleParty":32,"collaborators":30,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":30,"enrollmentInfo":43,"targetDuration":30,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":53,"overallStatus":60,"whyStopped":30,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":30},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"drug administration","EXPERIMENTAL","Botox Injection",[13],"Drug: BOTOX INJECTION",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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.\n\nThe 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).\n\nIn the event of multiple lesions, a single limb is injected based on clinical severity (ulcer, gangrene) and ischemia parameters (lowest TCPO2).",[9],[21],"botulinum toxin",[23],{"name":24,"affiliation":5,"role":25},"Julie Malloizel-Delaunay, MD","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","05 61 32 30 33",null,"malloizel-delaunay.j@chu-toulouse.fr",{"type":33,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100492963","phase-3-evaluation-of-botulinum-toxin-type-a-in-the-treatment-of-buergers-disease-100492963",false,"NCT05698979","Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease","BETOX","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. patient with Buerger's disease according to Olin criteria (ref)\n3. with digital ischemia with critical upper or lower limb ischemia criteria defined as Upper limb: pain and\u002For trophic disorders for at least 15 days AND digital pressure less than 50 mmHg Or TCPO2 30 mmHg) Or\u002Fand Lower limb: pain and\u002For 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).\n4. Ability to attend study visits\n5. Ability to complete daily study agenda\n6. Ability to give free and informed consent\n7. Membership of a Social Security scheme\n\nExclusion Criteria:\n\n1. History of myasthenia gravis or Eaton-Lambert syndrome\n2. History of inflammatory myositis for less than 2 years or pre-existing motor neuron disease or superior limb neuropathy.\n3. Known allergy to botulinum toxin or cream lidocaine, albumin or inhaled nitrous oxide\u002Foxygen.\n4. Progressive infection of one hand or foot\n5. Aminoglycoside treatment\n6. Pregnant or nursing women\n7. History of vascular surgery of surgical sympathectomy of upper or lower limb\n8. Revascularization procedure considered within 3 months of inclusion\n9. Risk of major amputation within 3 months of inclusion\n10. Iloprost expected within one month of study treatment\n11. Hyperbaric chamber sessions scheduled within one month of study treatment\n12. Life expectancy less than 6 months\n13. Contraindication to one or more of the following products: BOTOX 100 UNITS ALLERGAN, LIDOCAINE\u002FPRILOCAINE 5%, cream or NITROUS OXIDE MEDICINAL\n14. Patients treated by class III anti arhythmic drugs for example amiodarone 15 ) Patient with guardians, curators, or protection of justice","ALL","18 Years",{"count":44,"type":45},8,"ESTIMATED","INTERVENTIONAL",[48],"PHASE3","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.",[51,52],"Buerger Disease","Raynaud Syndrome",[54,55,56,57,58,59],"botulinum toxin A","botox","feasibility","raynaud","buerger","tolerance","NOT_YET_RECRUITING","2026-05-28",{"date":63,"type":64},"2026-06-01","ACTUAL",{"date":66,"type":45},"2027-01-01",{"date":68,"type":45},"2028-02",{"name":5,"class":6}]