Clinical trial NCT04757766: VAP-PRO-C6. Effectiveness and Tolerability of Venoactive Drugs in Combination Therapy in Patients With CVD (CEAP 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Venous Insufficiency
Lead sponsor: Servier Russia
Sponsor class: INDUSTRY
First posted: 2021-02-17
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: patients with venous ulcers (CEAP classes C6) treated in real clinical settings

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy
timeFrame: 6 months
measure: Eeffectiveness of Systemic Pharmacotherapy
timeFrame: 6 months
Secondary outcomes:
measure: Healing of the Reference Venous Ulcers #1
timeFrame: 3 months
measure: Healing of the Reference Venous Ulcers at Visit 3 vs Baseline
timeFrame: 6 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: The first Phlebological Center
Study officials:
References: