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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
BOTOX INJECTION
DrugThe 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. The 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). In the event of multiple lesions, a single limb is injected based on clinical severity (ulcer, gangrene) and ischemia parameters (lowest TCPO2).
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: drug administrationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility in Number of patients
The feasibility criterion corresponds to the number of patients who actually received the planned injections within the defined time limits, among the patients who should have received the injection according to the criteria of the protocol.
Time frame
through study completion, an average of 18 monthsSecondary outcomes
1
tolerance of participants
collection of temporary low grade adverse events (hematoma, erythema, ecchymosis at the injection site, pain, before/after and during injection)
Time frame
during injection2
tolerance of participants
collection of temporary low grade adverse events (hematoma, erythema, ecchymosis at the injection site, pain, before/after and during injection)
Time frame
2 hours after injection3
tolerance during injection
collection of temporary high grade adverse events (muscle weakness, temporary or prolonged headache, general muscle weakness or muscle group at distance from injection site, difficulty swallowing, dyspnea, immediate allergic reaction to injections)
Time frame
during injection4
tolerance after injection
collection of temporary high grade adverse events (muscle weakness, temporary or prolonged headache, general muscle weakness or muscle group at distance from injection site, difficulty swallowing, dyspnea, immediate allergic reaction to injections)
Time frame
2 hours after injectionSponsors and contacts
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Source ClinicalTrials.gov
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