Clinical Trial

Topical Sevoflurane for Treatment of Chronic Leg Ulcers

Recruiting Phase 4
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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.
Summary
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
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-03-21; most recent amendment 2024-08-24.
Status change: Not Yet Recruiting → Recruiting 2022-05-19
Trial Details
NCT Number NCT05303805
Lead Sponsor Charles University, Czech Republic
Collaborators: Faculty Hospital Kralovske Vinohrady
Conditions Leg Ulcer
Enrollment 50 participants
Start Date 2022-05-02
Primary Completion 2026-04-30 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2024-08-27