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Topical Sevoflurane for Treatment of Chronic Leg Ulcers

NCT05303805 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-08-27

No results posted yet for this study

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

Conditions

  • Leg Ulcer

Interventions

DRUG

Sevoflurane

Topical application of 1 mL sevoflurane per 1 cm2 ulcer area once or two times daily.

COMBINATION_PRODUCT

Cyteal

Rinsing and cleaning of ulcer.

Sponsors & Collaborators

  • Faculty Hospital Kralovske Vinohrady

    collaborator OTHER_GOV

  • Charles University, Czech Republic

    lead OTHER

Principal Investigators

  • Jiří Málek, M.D. · 3rd Medical Faculty of Charles University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-02
Primary Completion
2026-04-30
Completion
2027-01-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05303805 on ClinicalTrials.gov