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

Chronic Venous Insufficiency Clinical Trial

— VAP-PRO-C6  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04757766
• Other study ID #: IC4-05682-066-RUS
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2022
• Source: Servier Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Intervention

Drug:
• in daily everyday routine practice
The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation.

Locations

Country	Name	City	State
Russian Federation	The first Phlebological Center	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Servier Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Eeffectiveness of systemic pharmacotherapy	% of patients with reduction in the CVD clinical class by CEAP classification	6 months
Secondary	healing of the reference venous ulcers #1	% of patients with healed reference VU after 3 months of treatment	3 months
Secondary	healing of the reference venous ulcers #2	change in the area of reference VU in cm² (measured with LesionMeter application)	6 months