Using sevoflurane to treat chronic leg ulcers
Analgesic and Healing Effect of Topical Sevoflurane for Chronic Venous Ulcers
This study tests if using sevoflurane on painful leg ulcers can help reduce pain and improve healing compared to a regular rinse solution.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charles University, Czech Republic Academic / other |
| Locations | 1 site (Prague) |
| Trial ID | NCT05303805 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of topical sevoflurane in treating painful, non-healing leg ulcers. Patients will be randomly assigned to receive either sevoflurane or a standard rinse solution during their wound treatment. The study will monitor pain intensity, microbial colonization, and the healing process over a period of five days. The primary focus is on pain relief, with secondary outcomes related to ulcer healing and microbial management.
Who should consider this trial
Good fit: Ideal candidates are patients suffering from painful, non-healing tibial venous ulcers with a pain intensity rating above 4.
Not a fit: Patients with an allergy to sevoflurane or those unable to understand the pain-intensity questionnaire will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce pain and improve healing outcomes for patients with chronic leg ulcers.
How similar studies have performed: While the use of sevoflurane in this context is novel, similar approaches in pain management and wound healing have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Prague
- Faculty Hospital Kralovske Vinohrady — Prague, Czechia (Recruiting)
Study contacts
- Principal investigator: Jiří Málek, M.D. — 3rd Medical Faculty of Charles University
- Study coordinator: Jiri Malek, M.D.
- Email: malekj@fnkv.cz
- Phone: +4202671622461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.