Topical Sevoflurane for Treatment of Chronic Leg Ulcers

ConditionLeg Ulcer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCharles University, Czech Republic

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. 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

Qualifiers

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

Disqualifiers

Allergy to sevoflurane

Inability to understand the pain-intensity questionnaire

Trial design

Treatments tested in this trial

  • Sevoflurane
  • Cyteal

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Charles University, Czech Republic

Lead sponsor

Faculty Hospital Kralovske Vinohrady

Collaborator