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NCT Number: NCT05303805

Topical Sevoflurane for Treatment of Chronic Leg Ulcers

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty Hospital Kralovske Vinohrady

Prague, 100 00, Czechia

Location status: Recruiting

Location contact

Alice Kurzova, M.D.

SUB_INVESTIGATOR

Jiri Malek, M.D.

CONTACT

Spyridon Gkalpakiotis, M.D.

SUB_INVESTIGATOR

About this study

A prospective single-blinded randomized study will be conducted in patients of the Dermatovenereology Clinic of the 3rd Medical Faculty of Charles University (3LF UK) and the University Hospital Kralovske Vinohrady (FNKV) with painful non-healing tibial ulcers. Pain intensity on a numerical rating scale (NRS 0-10) must be NRS>4. The envelope method will be used for randomization. To blind patients, therapy will be performed by separating patients with a drape from the treatment area of the body. As sevoflurane has a typical odor, it will only be used in the control group to soak up absorbent material held under the distal pole of the wound without skin contact. In the active treatment group, sevoflurane will be applied at the beginning of the wound treatment at approximately 1 ml/cm2 of the ulcer surface. The standard therapy used in the control group will use only Cyteal TM lavage solution, which contains hexamidine diisetione 100 mg in 100 ml, chlorhexidine digluconate 20% solution 100 mg and chlorocresol 300 mg.

The primary aim of the study will be pain relief after sevoflurane therapy. Pain intensity will be measured by NRS at 1-hour intervals (excluding sleep); decrease of 2 point for at least 4 hours will be considered significant. Secondary aim will be healing of ulcers. The effect will be controlled by elimination of pathologic microbial colonization, cleaning of the base of the wound and decreasing the size of the ulcer. Microbial colonization will be measured by microbial swab culture before application, after the 1st application before dressing and on the 5th day after application), the appearance of the defect base will be assessed by the appearance of the surface, the size of the defect will be measured in cm2.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

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

Other names: Sevorane

Cyteal

Combination Product

Rinsing and cleaning of ulcer.

Primary outcomes

  1. Pain intensity

    Time frame: Continuously for 5 days

    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

Secondary outcomes

  1. Microbial colonization

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

    Microbial smear for culture

  2. Size of skin defect

    Time frame: 5 days

    Measured in cm2

  3. Appearance of the ulcer bed

    Time frame: 5 days

    Epithelial tissue, granulation tissue, slough, necrotic tissue

Study contacts

Contact information is provided by the study sponsor or research team.

Jiri Malek, M.D.

CONTACT

[email protected]

+4202671622461

Jiri Malek, M.D.

CONTACT

[email protected]

+4202671622272461

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • Faculty Hospital Kralovske Vinohrady

Registry information

Official study title

Analgesic and Healing Effect of Topical Sevoflurane for Chronic Venous Ulcers

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Mar 31, 2022
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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