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NCT05698979
Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
Conditions: Buerger Disease, Raynaud Syndrome
Sex: All
Ages: 18 Years – N/A
Phase: PHASE3
Enrollment: 8
Sponsor: University Hospital, Toulouse
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.
Eligibility Criteria
Inclusion Criteria:Age ≥ 18 yearspatient 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 visitsAbility to complete daily study agendaAbility to give free and informed consentMembership of a Social Security schemeExclusion Criteria:History of myasthenia gravis or Eaton-Lambert syndromeHistory 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 footAminoglycoside treatmentPregnant or nursing womenHistory of vascular surgery of surgical sympathectomy of upper or lower limbRevascularization procedure considered within 3 months of inclusionRisk of major amputation within 3 months of inclusionIloprost expected within one month of study treatmentHyperbaric chamber sessions scheduled within one month of study treatmentLife expectancy less than 6 monthsContraindication to one or more of the following products: BOTOX 100 UNITS ALLERGAN, LIDOCAINE/PRILOCAINE 5%, cream or NITROUS OXIDE MEDICINALPatients treated by class III anti arhythmic drugs for example amiodarone 15 ) Patient with guardians, curators, or protection of justice
Source: ClinicalTrials.gov (NCT05698979). StuddyBuddy aggregates publicly available trial information.