Topical Sevoflurane for Treatment of Chronic Leg Ulcers

Recruiting now · Phase 4

Conditions studied: Leg Ulcer

In brief

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

Key facts

Study ID

NCT05303805

Run by

Charles University, Czech Republic

People needed

50

Starts

2022-05-02

Expected to finish

2027-01-31

Last updated by the study team

2024-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Allergy to sevoflurane
• Inability to understand the pain-intensity questionnaire

Where it is running

• Faculty Hospital Kralovske Vinohrady — Prague, Czechia (enrolling)

Full record on ClinicalTrials.gov

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