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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.
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 at Visit 3 vs Baseline | change in the area of reference VU in cm² (measured with LesionMeter application) |
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Inclusion Criteria:
Exclusion Criteria:
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patients with venous ulcers (CEAP classes C6) treated in real clinical settings
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first Phlebological Center | Moscow | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
patients with venous ulcers (CEAP classes C6) treated in daily clinical practice
The reference VU must meet the following criteria:
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy | % of patients with complete healing of the reference venous ulcer after 6 months | Posted | Count of Participants | Participants | 6 months |
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|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| exacerbation of chronic gastritis | Gastrointestinal disorders | MedDRA v.25.1. | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| olga linnik | Servier | 8-495-93707-00 | olga.linnik@servier.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 23, 2020 | Apr 17, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 23, 2020 | Apr 17, 2024 | ICF_001.pdf |
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| 6 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Eeffectiveness of Systemic Pharmacotherapy | % of patients with reduction in the CVD clinical class by CEAP classification | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Healing of the Reference Venous Ulcers #1 | % of patients with healed reference VU after 3 months of treatment | Posted | Count of Participants | Participants | 3 months |
|
|
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| 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) | Posted | Mean | Standard Deviation | cm² | 6 months |
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| 0 |
| 349 |
| 0 |
| 349 |
| 1 |
| 349 |
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