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Evaluation of Botulinum TOXin Type A in the Treatment of Buerger's Disease

Study acronym: BETOX
StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 0 to 1v5
  2. Primary and study completion dates: Feb 2026 to Feb 2028 Start date: Jan 1, 2025 to Jan 1, 2027v4 Show 1 more changeShow less
    • Start date: Jan 1, 2025 to Jan 1, 2027
  3. Primary and study completion dates: Jun 1, 2024 to Feb 2026 Start date: Aug 30, 2023 to Jan 1, 2025v3 Show 1 more changeShow less
    • Start date: Aug 30, 2023 to Jan 1, 2025
  4. Start date: Jan 30, 2023 to Aug 30, 2023 Secondary endpoints revised (4)v2 Show 1 more changeShow less
    • Secondary endpoints revised (4)

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05698979
Lead Sponsor University Hospital, Toulouse
Conditions Buerger Disease, Raynaud Syndrome
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov