Chronic Venous InsufficiencyVAP-PRO-C6NCT04757766

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

An observational study of Chronic Venous Insufficiency, run by Servier Russia at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Chronic Venous Insufficiency
What is being tested?: in daily everyday routine practice
How many people: 350 participants
Where: 1 siteRussia
Study dates: 1 Mar 2021to 31 May 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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.)

Trial locations and contacts

1 site in 1 country.

Russia1 site

The first Phlebological Center
Moscow

Other trials in Russia

About this study

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

Read the 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.

Conditions: Chronic Venous Insufficiency
Being tested: in daily everyday routine practice

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

in daily everyday routine practiceDrug
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy
% of patients with complete healing of the reference venous ulcer after 6 months
Measured: 6 months
Eeffectiveness of Systemic Pharmacotherapy
% of patients with reduction in the CVD clinical class by CEAP classification
Measured: 6 months

Secondary outcomes (2)

Healing of the Reference Venous Ulcers #1
% of patients with healed reference VU after 3 months of treatment
Measured: 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)
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202131 May 2022

First posted17 Feb 2021
Study start1 Mar 2021
Primary completion31 May 2022
Study completion31 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Other
Enrolment: 350 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04757766
Sponsor's protocol ID: IC4-05682-066-RUS
Acronym: VAP-PRO-C6
Status last verified: Apr 2024
First submitted: 12 Feb 2021
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Venous Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04757766
Acronym / sponsor ID: VAP-PRO-C6 / IC4-05682-066-RUS
Conditions: Chronic Venous Insufficiency
Study type: Observational
Recruitment status: Completed
Enrolment: 350 participants (actual)
Lead sponsor: Servier RussiaIndustry (pharma, biotech, devices)
Study start: 1 Mar 2021 (actual)
Primary completion: 31 May 2022 (actual)
Study completion: 31 May 2022 (actual)
First posted: 17 Feb 2021 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The planned number of patients is 350.

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 design

Observational model: Other
Time perspective: Other

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: patients with venous ulcers (CEAP classes C6) treated in real clinical settings

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
in daily everyday routine practiceThe 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.	Drug	–

Primary outcome

Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy
Time frame: 6 months
% of patients with complete healing of the reference venous ulcer after 6 months
Eeffectiveness of Systemic Pharmacotherapy
Time frame: 6 months
% of patients with reduction in the CVD clinical class by CEAP classification

2 secondary outcomes

Healing of the Reference Venous Ulcers #1
Time frame: 3 months
Healing of the Reference Venous Ulcers at Visit 3 vs Baseline
Time frame: 6 months

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice	349	349

Primary outcome: Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice n = 349
Value	243

Primary outcome: Eeffectiveness of Systemic Pharmacotherapy

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice n = 349
Value	247

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0.29% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Venous Ulcers (CEAP Classes C6) Treated in Daily Clinical Practice	0 of 349 (0%)	1 of 349 (0.3%)	0 of 349

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Active, not recruiting
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The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
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Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Venous Insufficiency, run by Servier Russia at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Eeffectiveness of Systemic Pharmacotherapy as a Part of Combination Therapy (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04757766.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.