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

NCT04757766 | Completed Results

• 1 other identifier: IC4-05682-066-RUS
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Venous Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Healing of the Reference Venous Ulcers #1

  3 months

• Healing of the Reference Venous Ulcers at Visit 3 vs Baseline

  6 months

Interventions

in daily everyday routine practice DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• CVD documented by venous DUS
• Age over 18 years
• Written informed consent is provided
• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Servier Russia: lead

Study Sites (1)

The first Phlebological Center

Moscow, Russia

Location

Results Point of Contact

• Title: olga linnik
• Organization: Servier

olga.linnik@servier.com

8-495-93707-00

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 17, 2021
• Study Start: March 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)