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

Servier

Status: Completed

Conditions: Chronic Venous Insufficiency

Treatments: Drug: in daily everyday routine practice

Study type: Observational

Funder types: Industry

Identifiers

NCT04757766

IC4-05682-066-RUS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design