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

VAP-PRO-C6. Effectiveness and Tolerability of Venoactive Drugs in Combination Therapy and Their Effect on the Overall Treatment Outcomes in Patients With Chronic Venous Diseases of CEAP Classes C6 in Real Clinical Practice

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.

Study Overview

• Status: Completed
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Drug: in daily everyday routine practice

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 Type: Observational
• Enrollment (Actual): 350

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • The first Phlebological Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with venous ulcers (CEAP classes C6) treated in real clinical settings

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eeffectiveness of systemic pharmacotherapy as a part of combination therapy	% of patients with complete healing of the reference venous ulcer after 6 months	6 months
Eeffectiveness of systemic pharmacotherapy	% of patients with reduction in the CVD clinical class by CEAP classification	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
healing of the reference venous ulcers #1	% of patients with healed reference VU after 3 months of treatment	3 months
healing of the reference venous ulcers #2	change in the area of reference VU in cm² (measured with LesionMeter application)	6 months

Collaborators and Investigators

• Sponsor: Servier Russia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: IC4-05682-066-RUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No