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Topical Sevoflurane for Treatment of Chronic Leg Ulcers

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 27, 2024 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary completion date: Apr 30, 2024 to Apr 30, 2026
    • Study completion date: Jan 31, 2025 to Jan 31, 2027
    v5
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  4. Notable Start date: Mar 21, 2022 to May 2, 2022
    • Primary completion date: Mar 31, 2024 to Apr 30, 2024
    • Study description expanded, about 53 words
    v2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Patients with painful non-healing leg ulcer will be enrolled in the clinical single-blinded randomized study. The active treatment group will have sevoflurane applied at approximately 1 ml/cm2 at the start of wound treatment, the control group will only have a standard rinse solution with Cyteal TM (Pierre Fabre Medicament, France). Further treatment will then be carried out in the standard manner. The duration of the study will be 5 days; if the defect heals earlier, it will be terminated early. Exclusion criteria: allergy to sevoflurane, inability to understand the questionnaire Parameters to be monitored will be pain intensity, microbial colonization, appearance and size of the defect
Trial Details
NCT Number NCT05303805
Lead Sponsor Charles University, Czech Republic
Collaborators: Faculty Hospital Kralovske Vinohrady
Conditions
(from sponsor)
Leg Ulcer
Related terms Communicable Diseases, Leg Ulcer, Pain
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov