Status:
COMPLETED
VAP-PRO-C6. Effectiveness and Tolerability of Venoactive Drugs in Combination Therapy in Patients With CVD (CEAP C6)
Lead Sponsor:
Servier Russia
Conditions:
Chronic Venous Insufficiency
Eligibility:
All Genders
18+ years
Brief Summary
The VAP-PRO-C6 is a Russian multicenter observational program to be implemented at the routine visits and assessments. The program will include patients with chronic venous disease of CEAP classes C6....
Detailed Description
Aim of the program is to describe effectiveness and tolerability of systemic pharmacotherapy as a part of combination therapy and its effect on the overall treatment outcomes in patients with venous u...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04757766
Start Date
March 1 2021
End Date
May 31 2022
Last Update
September 19 2024
Active Locations (1)
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1
The first Phlebological Center
Moscow, Russia