Topical Sevoflurane for Treatment of Chronic Leg Ulcers

NCT05303805 | Recruiting Phase 4

• 1 other identifier: Sevoflurane in ulcers
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Leg Ulcer

Keywords

Leg Ulcer; Sevoflurane; Pain; Healing ulcer; Microbial colonization

Outcome Measures

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

  Continuously for 5 days

Secondary Outcomes (3)

• Microbial colonization

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

• Size of skin defect

  5 days

• Appearance of the ulcer bed

  5 days

Study Arms (2)

Topical sevoflurane

EXPERIMENTAL

The active treatment group will have sevoflurane applied at approximately 1 ml/cm2 at the start of wound treatment,

Drug: Sevoflurane

Cyteal

ACTIVE COMPARATOR

the control group will only have a standard rinse solution with Cyteal PIERRE FABRE MEDICAMENT, France (100 ml of skin fluid contains hexamidine diisetione 100 mg, chlorohexidine digluconate (solutio 20 %) 100 mg and chlorocresol 300 mg), with sevoflurane used to soak the absorbent material held under the distal pole of the wound.

Combination Product: Cyteal

Interventions

Sevoflurane DRUG

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

Also known as: Sevorane

Topical sevoflurane

Cyteal COMBINATION_PRODUCT

Rinsing and cleaning of ulcer.

Cyteal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Faculty Hospital Kralovske Vinohrady: collaborator

Study Sites (1)

Faculty Hospital Kralovske Vinohrady

Prague, 100 00, Czechia

RECRUITING

MeSH Terms

Conditions

Leg Ulcer; Pain; Communicable Diseases

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Jiří Málek, M.D.

  3rd Medical Faculty of Charles University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiri Malek, M.D.

CONTACT

+4202671622461; malekj@fnkv.cz

Jiri Malek, M.D.

CONTACT

+4202671622272461; malekj@fnkv.cz

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient will separated by a screen from the treated area. Absorbent material with sevoflurane will be held under the distal pole of the wound to produce a typical smell of sevoflurane.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Jiri Malek, MD, Ph.D.

Model Details: The intervention 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 , with sevoflurane used to soak the absorbent material held under the distal pole of the wound to produce a typical smell of sevoflurane.

Study Record Dates

• First Submitted: February 27, 2022
• First Posted: March 31, 2022
• Study Start: May 2, 2022
• Primary Completion: April 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

CZ (1)