drugset / Trial / NCT05303805

Topical Sevoflurane for Treatment of Chronic Leg Ulcers

NCT05303805

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

EvaluationDrugModalityDoseRoute
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

Indications