VAP-PRO-C6. Effectiveness and Tolerability of Venoactive Drugs in Combination Therapy in Patients With CVD (CEAP C6)

Completed

• Conditions: Chronic Venous Insufficiency

• Registration Number: NCT04757766
• Lead Sponsor: Servier Russia

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. This program is planned to be carried out in Russia in 2021-2022.

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 ulcers (CEAP classes C6) treated in real clinical settings.

The planned number of patients is 350.

The inclusion period lasts for 6 months. The treatment will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation. The following objective methods will be used to assess the changes in the skin condition:

* measurement of the area of reference ulcer (using LesionMeter\*) before and after the treatment;

* changes in status localis.

* The presence and location of venous reflux and/or occlusion. The study does not implicate any intervention to routine management of patients with chronic venous disease (CVD). In particular, in this study the parameters that are usually evaluated during the examination of patients with classes C6 CVD (CEAP) will be recorded. Special attention will be paid to evaluating changes of the area of referent VU using objective methods (measuring ulcer area using LesionMeter, time to ulcer healing).

* LesionMeter is a generally available tool for measuring the venous ulcer area.

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-17
• Study Start: 2021-03-01
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-11
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy	6 months	% of patients with complete healing of the reference venous ulcer after 6 months
Eeffectiveness of Systemic Pharmacotherapy	6 months	% of patients with reduction in the CVD clinical class by CEAP classification

Secondary Outcome Measures

Name	Time	Method
Healing of the Reference Venous Ulcers #1	3 months	% of patients with healed reference VU after 3 months of treatment
Healing of the Reference Venous Ulcers at Visit 3 vs Baseline	6 months	change in the area of reference VU in cm² (measured with LesionMeter application)

Trial Locations

Locations (1)

The first Phlebological Center; 🇷🇺 Moscow, Russian Federation