Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- BOTOX INJECTION
Treatment groups
8 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov