Overview

Topical Sevoflurane for Treatment of Chronic Leg Ulcers

Status:
Not yet recruiting

Trial end date:
2025-01-31

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Charles University, Czech Republic

Collaborator:

Faculty Hospital Kralovske Vinohrady

Treatments:

Sevoflurane

Criteria

Inclusion Criteria:

- Patients with painful (pain intensity on the numerical scale NRS 0-10 is NRS>4) non-
healing tibial venous ulcers

Exclusion Criteria:

- Allergy to sevoflurane

- Inability to understand the pain-intensity questionnaire