Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-24 @ 4:12 PM
NCT ID:
NCT04757766
Eligibility Criteria:
Inclusion Criteria:
* CVD documented by venous DUS
* Age over 18 years
* Written informed consent is provided
* No treatment with venoactive drugs within 4 weeks prior to inclusion in the study
* Presence of a primary /active venous ulcer (class C6/ CEAP) that meets criteria for the referent ulcer
* No surgical intervention or procedure (including sclerotherapy) for CVD is planned
Exclusion Criteria:
* Withdrawal of the informed consent
* Pregnancy or willingness to become pregnant within at least 2 months after the end of the study
* Indications for surgery (including sclerotherapy)
* Serious violation or non adherence to the prescribed therapy/ regimen
* Use of prohibited drugs that can cause edema of lower extremities (calcium channel blockers, hormonal agents, NSAIDs, etc.)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04757766
Study Brief:
Protocol Section:
NCT04757766