Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Recruiting
Phase 4
Interventional Study
Leg Ulcer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Charles University, Czech Republic · Other
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About This Trial
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…
Trial Locations
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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
Contacts