Chronic Venous Insufficiency
Conditions
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.
Interventions
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.
Sponsors
Servier Russia
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy | 6 months | % of patients with complete healing of the reference venous ulcer after 6 months |
| Eeffectiveness of Systemic Pharmacotherapy | 6 months | % of patients with reduction in the CVD clinical class by CEAP classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healing of the Reference Venous Ulcers #1 | 3 months | % of patients with healed reference VU after 3 months of treatment |
| Healing of the Reference Venous Ulcers at Visit 3 vs Baseline | 6 months | change in the area of reference VU in cm² (measured with LesionMeter application) |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical 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 Particular attention was paid to determining the reference Venous ulcer (VU) area dynamics using the objective methods (measurement of ulcer area and ulcer healing time). | 349 |
| Total | 349 |
Baseline characteristics
| Characteristic | Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 179 Participants | — |
| Age, Categorical Between 18 and 65 years | 170 Participants | — |
| Age, Continuous | 60.95 years STANDARD_DEVIATION 12.71 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Russia | 349 Participants | — |
| Sex: Female, Male Female | 233 Participants | — |
| Sex: Female, Male Male | 116 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 349 |
| other Total, other adverse events | 1 / 349 |
| serious Total, serious adverse events | 0 / 349 |
Outcome results
Primary
Eeffectiveness of Systemic Pharmacotherapy
% of patients with reduction in the CVD clinical class by CEAP classification
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice | Eeffectiveness of Systemic Pharmacotherapy | 247 Participants |
Primary
Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy
% of patients with complete healing of the reference venous ulcer after 6 months
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice | Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy | 243 Participants |
Secondary
Healing of the Reference Venous Ulcers #1
% of patients with healed reference VU after 3 months of treatment
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice | Healing of the Reference Venous Ulcers #1 | 47 Participants |
Secondary
Healing of the Reference Venous Ulcers at Visit 3 vs Baseline
change in the area of reference VU in cm² (measured with LesionMeter application)
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice | Healing of the Reference Venous Ulcers at Visit 3 vs Baseline | 8.02 cm² | Standard Deviation 4.06 |