Leg UlcerPhase 4NCT05303805
Topical Sevoflurane for Treatment of Chronic Leg Ulcers
A Phase 4 study testing Sevoflurane and Cyteal in people with Leg Ulcer, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcer
- What is being tested?
- Sevoflurane and Cyteal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 2 May 2022to 31 Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with painful (pain intensity on the numerical scale NRS 0-10 is NRS>4) non- healing tibial venous ulcers
Who cannot join
- Allergy to sevoflurane
- Inability to understand the pain-intensity questionnaire
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Faculty Hospital Kralovske Vinohrady
Prague, 100 00
Jiri Malek, M.D.
Spyridon Gkalpakiotis, M.D.
About this study
Official title: Analgesic and Healing Effect of Topical Sevoflurane for Chronic Venous 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
Read the detailed description
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.
- Conditions
- Leg Ulcer
- Being tested
- Sevoflurane, Cyteal
- Keywords
- Leg Ulcer, Sevoflurane, Pain, Healing ulcer, Microbial colonization
- Medical subject headings
- Leg Ulcer, Pain, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevorane
Topical application of 1 mL sevoflurane per 1 cm2 ulcer area once or two times daily.
CytealCombination product
Rinsing and cleaning of ulcer.
| Study group | Role | What they receive |
|---|---|---|
| Topical sevoflurane | Experimental | The active treatment group will have sevoflurane applied at approximately 1 ml/cm2 at the start of wound treatment, Receives: 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. Receives: Combination Product: Cyteal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Continuously for 5 days
Secondary outcomes (3)
Microbial colonization
Microbial smear for culture
Measured: Before application of treatment, after the 1st application before tibial coverage and on the 5th day after application
Size of skin defect
Measured in cm2
Measured: 5 days
Appearance of the ulcer bed
Epithelial tissue, granulation tissue, slough, necrotic tissue
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start2 May 2022
- Primary completion30 Oct 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcerStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Faculty Hospital Kralovske Vinohrady
- Responsible party
- Principal investigator, Jiri Malek, Charles University, Czech Republic
- Investigators
- Jiří Málek, M.D., Principal investigator, 3rd Medical Faculty of Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303805
- Sponsor's protocol ID
- Sevoflurane in ulcers
- Status last verified
- Oct 2026
- First submitted
- 27 Feb 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic and Healing Effect of Topical Sevoflurane for Chronic Venous Ulcers
- ClinicalTrials.gov ID
- NCT05303805
- Acronym / sponsor ID
- Sevoflurane in ulcers
- Conditions
- Leg Ulcer
- Keywords
- Leg Ulcer, Sevoflurane, Pain, Healing ulcer, Microbial colonization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Faculty Hospital Kralovske Vinohrady
- Study start
- 2 May 2022 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Topical sevoflurane | Experimental | Drug: SevofluraneThe active treatment group will have sevoflurane applied at approximately 1 ml/cm2 at the start of wound treatment, |
| Cyteal | Active comparator | Combination Product: Cytealthe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with painful (pain intensity on the numerical scale NRS 0-10 is NRS>4) non- healing tibial venous ulcers
Key exclusion criteria (2 listed)
- Allergy to sevoflurane
- Inability to understand the pain-intensity questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneAlso: SevoraneTopical application of 1 mL sevoflurane per 1 cm2 ulcer area once or two times daily. | Drug | Topical sevoflurane |
| CytealRinsing and cleaning of ulcer. | Combination product | Cyteal |
Primary outcome
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
3 secondary outcomes
Microbial colonization
Time frame: Before application of treatment, after the 1st application before tibial coverage and on the 5th day after application
Size of skin defect
Time frame: 5 days
Appearance of the ulcer bed
Time frame: 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiří Málek, M.D. principal investigator
3rd Medical Faculty of Charles University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane and Cyteal in people with Leg Ulcer, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiri Malek, M.D. (+4202671622461, malekj@fnkv.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Continuously for 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.