Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-27 @ 9:52 PM
Study NCT ID:
NCT04757766
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
VAP-PRO-C6. Effectiveness and Tolerability of Venoactive Drugs in Combination Therapy in Patients With CVD (CEAP C6)
Sponsor:
Servier Russia
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAP-PRO-C6
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: