drugset / Trial / NCT05303805
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Phase 4
Recruiting
50 enrolled
Charles University, Czech Republic
Faculty Hospital Kralovske Vinohrady · collab
RandomizedParallel-groupSingle-blindTreatment
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
Timeline
- Start
- 2022-05-02
- Primary completion
- 2026-04-30
- Completion
- 2027-01-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Chlorhexidine gluconate | Other / unclassified | 100 mg | — |
| Subject | Chlorocresol | Small molecule | 300 mg | — |
| Subject | Hexamidine diisetione | Unknown | 100 mg | — |
| Subject | Sevoflurane | Other / unclassified | 1 ml | Topical |