Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Sevoflurane

    Drug

    Topical application of 1 mL sevoflurane per 1 cm2 ulcer area once or two times daily.

  • Cyteal

    Combination product

    Rinsing and cleaning of ulcer.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Topical sevofluraneExperimental treatment 1 intervention
Group B: CytealActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain intensity

Pain intensity measured by numeric rating scale (NRS) from 0 - no pain (the best result) to 10 - the worst possible pain using a standard questionnaire

Time frame
Continuously for 5 days

Secondary outcomes

1

Microbial colonization

Microbial smear for culture

Time frame
Before application of treatment, after the 1st application before tibial coverage and on the 5th day after application
2

Size of skin defect

Measured in cm2

Time frame
5 days
3

Appearance of the ulcer bed

Epithelial tissue, granulation tissue, slough, necrotic tissue

Time frame
5 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charles University, Czech Republic

Lead sponsor

Faculty Hospital Kralovske Vinohrady

Collaborator

Source ClinicalTrials.gov
Apply now