NCT05303805 Topical Sevoflurane for Treatment of Chronic Leg Ulcers
| NCT ID | NCT05303805 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Charles University, Czech Republic |
| Condition | Leg Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-05-02 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2022-05-02 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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
Contact & Investigator
Jiří Málek, M.D.
PRINCIPAL INVESTIGATOR
3rd Medical Faculty of Charles University
Frequently Asked Questions
Who can join the NCT05303805 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Leg Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05303805 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05303805 currently recruiting?
Yes, NCT05303805 is actively recruiting participants. Contact the research team at malekj@fnkv.cz for enrollment information.
Where is the NCT05303805 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT05303805 clinical trial?
NCT05303805 is sponsored by Charles University, Czech Republic. The principal investigator is Jiří Málek, M.D. at 3rd Medical Faculty of Charles University. The trial plans to enroll 50 participants.