Chronic Venous DiseaseVAP-PRO-C3NCT03722836
Evaluation of the Efficacy and Tolerability of Detralex in Patients With Chronic Venous Edema in Real Clinical Practice
An observational study of Chronic Venous Disease, run by Servier Russia at 1 site in Russia.
Trial summary
The VAP-PRO-C3 is a multicenter observational program, which is carried out in the frame of routine consultations and follow-up of patients. The program includes patients with chronic venous diseases (CVDs) of CEAP class C3. It is scheduled in Russia for 2018-2019. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Chronic Venous Disease
- How many people
- 708 participants
- Where
- 1 siteRussia
- Study dates
- 6 Dec 2018to 20 Jun 2019
- 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 to 79 years
- All sexes
- Adult, Older adult
Study population: Patients with CVD
Who may be able to join
- Age 18 years old or above
- Written informed consent
- Patient did not receive treatment with venoactive drugs within the past 4 weeks prior to the inclusion in the study
- Diagnosis of chronic venous disease of class C3 (CEAP)
- Decision of an attending physician to prescribe Detralex.
Who cannot join
- Age below 18 years old
- Written informed consent is not obtained
- History of alcohol or drug abuse or use of narcotic drugs
- History of allergic reaction to diosmin or any other venoactive agent, or their intolerance
- History of allergic reaction to anesthetics and/or sclerosing agents
- Chronic venous disease of СЕАР class C0-С2 or class С4-С6
Show all 26Show fewer
- Lymphatic edema of the lower extremities
- Secondary varicose veins, angiodysplasia, or neoplasia
- Arterial disease (ankle-brachial index <0.9)
- Infection within the past 6 weeks
- Any of the following concomitant diseases, which can affect the results:
- Connective tissue disease (including rheumatoid arthritis), arthritis
- Heart failure
- Intermittent claudication (peripheral artery disease)
- Diseases of the bones or joints of the lower extremities
- Malignancy
- Treatment with drugs potentially causing leg edema (calcium channel blockers, hormonal drugs, NSAIDs, etc.)
- History of deep vein thrombosis (within the past year)
- History of superficial thrombophlebitis (within the past 3 months)
- Patient cannot walk (regardless of the cause)
- Obesity or body mass index [BMI] >30 kg/m2 [BMI = body mass (kg)/height (m)2]
- Predictable poor adherence to treatment
- Participation of the patient in the intervention study within the previous 3 months
- For women: pregnancy or breastfeeding, the desire to become pregnant within at least 2 months after the study
- Patient cannot attend a follow-up visit
- Patients with a contraindication to diosmin-containing agents, including Detralex
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Observational Program Evaluation of the Efficacy and Tolerability of Detralex Treatment in Patients With Chronic Venous Edema (CEAP Class С3) in Real Clinical Practice
The VAP-PRO-C3 is a multicenter observational program, which is carried out in the frame of routine consultations and follow-up of patients. The program includes patients with chronic venous diseases (CVDs) of CEAP class C3. It is scheduled in Russia for 2018-2019. The program is expected to enroll 90 phlebologists from 60 cities of Russia. The planned number of patients is 900
Read the detailed description
The study is aimed at evaluating the efficacy and safety of systemic pharmacotherapy (Detralex) as a part of combination treatment, and its influence on the general outcomes of treatment of patients with chronic venous edema (CEAP class C3) in real clinical practice.
Each investigator is planned to include in the program 10 patients fulfilling the inclusion criteria. The treatment will be carried out in accordance to the routine clinical practice, instructions for the medical use of drugs, and a specific clinical situation. To assess changes in edema, the method of truncated cones and duplex ultrasound scanning (DUS) will be used.
- Conditions
- Chronic Venous Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4
Visual Analog Scale (VAS) was used in the VAP-PRO-C3 study in to discribe 5 criterions: 1.leg heaviness, 2.pain, 3. sensation of swelling, 4. night cramps 5. itching reduced from Description of the technique: It is a continuous scale in the form of a horizontal line 100 mm long with two extreme points located on it: "no symptom" and "the strongest symptom you can imagine." The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his symptom intensity. The ruler measures the distance (mm) between "no symptom" and "the strongest symptom you can imagine," providing a score range from 0 to 100. A higher score indicates a greater intensity of symptom.
Measured: 3 months
Changes in the Severity of Edema, as Assessed by the Method of Truncated Cones.
To assess changes in edema, the method of truncated cones and duplex ultrasound scanning (DUS) will be used.
The method is based on the assumption that the shape of the lower extremity approaches the shape of several truncated cones connected by bases that coincide in area. The volume of the cone is calculated by measuring the circumference of the upper (C) and lower (c) cones and the height (h) between them. For calculating the volume of each cone, the following formula is used:
V = (p / 12p) ² h (C² + Cc + c²), The volume of the lower limb is determined by summing the volumes of all the cones. The smaller the height of the segments, the more accurate the result.
Measured: 3 months
Secondary outcomes (1)
Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4
Chronic Venous Insufficiency Questionnaire (CIVIQ-14) is a specific questionnaire for venous disease. It was used to describe the patients quality of life.
Questionnaire consists of 3 dimenions: 1. pain in ankles or legs 2. scale of physical condition 3.influence to psychological state It is a SELF-reported survey where each patient has to circle the number (from 1 to 5): of which 1 means NO signs or symptons (the best result) and 5 stands for the worst state CIVIQ 14 consists of 14 questions, each question has a maximum score of 5 points. So 70 points indicates maximum reduced QoL, and 14 - best state of QoL.
In order to compare the mean scores between dimensions, absolute scores were converted into an index. For each dimension, we obtained a result ranging from 0 to 100. Interpretation: the highest figure can be allocated to the lowest response option and vice versa.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start6 Dec 2018
- Primary completion15 Jun 2019
- Study completion20 Jun 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous DiseaseStudies 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
- Prospective
- Enrolment
- 708 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Russia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuriy Stoyko, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722836
- Sponsor's protocol ID
- IC4-05682-055-RUS
- Acronym
- VAP-PRO-C3
- Status last verified
- Apr 2022
- First submitted
- 22 Oct 2018
- Last updated
- 13 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bogachev VI, Boldin BV, Turkin PI, Samenkov AI; Study Group VAP-PRO-C3. [Comparative efficacy of various methods of treatment of chronic venous oedema in real clinical practice]. Angiol Sosud Khir. 2021;27(3):77-83. doi: 10.33529/ANGIO2021310. Russian.
PubMed 34528591
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observational Program Evaluation of the Efficacy and Tolerability of Detralex Treatment in Patients With Chronic Venous Edema (CEAP Class С3) in Real Clinical Practice
- ClinicalTrials.gov ID
- NCT03722836
- Acronym / sponsor ID
- VAP-PRO-C3 / IC4-05682-055-RUS
- Conditions
- Chronic Venous Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- Servier RussiaIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 29 Oct 2018 (actual)
- Results
- Posted 13 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The VAP-PRO-C3 is a multicenter observational program, which is carried out in the frame of routine consultations and follow-up of patients. The program includes patients with chronic venous diseases (CVDs) of CEAP class C3. It is scheduled in Russia for 2018-2019. The program is expected to enroll 90 phlebologists from 60 cities of Russia. The planned number of patients is 900
Detailed description
The study is aimed at evaluating the efficacy and safety of systemic pharmacotherapy (Detralex) as a part of combination treatment, and its influence on the general outcomes of treatment of patients with chronic venous edema (CEAP class C3) in real clinical practice.
Each investigator is planned to include in the program 10 patients fulfilling the inclusion criteria. The treatment will be carried out in accordance to the routine clinical practice, instructions for the medical use of drugs, and a specific clinical situation. To assess changes in edema, the method of truncated cones and duplex ultrasound scanning (DUS) will be used.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with CVD
Key inclusion criteria (5 listed)
- Age 18 years old or above
- Written informed consent
- Patient did not receive treatment with venoactive drugs within the past 4 weeks prior to the inclusion in the study
- Diagnosis of chronic venous disease of class C3 (CEAP)
- Decision of an attending physician to prescribe Detralex.
Key exclusion criteria (26 listed)
- Age below 18 years old
- Written informed consent is not obtained
- History of alcohol or drug abuse or use of narcotic drugs
- History of allergic reaction to diosmin or any other venoactive agent, or their intolerance
- History of allergic reaction to anesthetics and/or sclerosing agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4
Time frame: 3 months
Visual Analog Scale (VAS) was used in the VAP-PRO-C3 study in to discribe 5 criterions: 1.leg heaviness, 2.pain, 3. sensation of swelling, 4. night cramps 5. itching reduced from Description of the technique: It is a continuous scale in the form of a horizontal line 100 mm long with two extreme points located on it: "no symptom" and "the strongest symptom you can imagine." The patient is asked to place a line perpendicularly crossing the visual analogue scale at the point that corresponds to his symptom intensity. The ruler measures the distance (mm) between "no symptom" and "the strongest symptom you can imagine," providing a score range from 0 to 100. A higher score indicates a greater intensity of symptom.
Changes in the Severity of Edema, as Assessed by the Method of Truncated Cones.
Time frame: 3 months
To assess changes in edema, the method of truncated cones and duplex ultrasound scanning (DUS) will be used. The method is based on the assumption that the shape of the lower extremity approaches the shape of several truncated cones connected by bases that coincide in area. The volume of the cone is calculated by measuring the circumference of the upper (C) and lower (c) cones and the height (h) between them. For calculating the volume of each cone, the following formula is used: V = (p / 12p) ² h (C² + Cc + c²), The volume of the lower limb is determined by summing the volumes of all the cones. The smaller the height of the segments, the more accurate the result.
1 secondary outcome
Patients' Quality of Life According to CIVIQ-14 - Visit 0 vs Visit4
Time frame: 3 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34528591Bogachev VI, Boldin BV, Turkin PI, Samenkov AI; Study Group VAP-PRO-C3. [Comparative efficacy of various methods of treatment of chronic venous oedema in real clinical practice]. Angiol Sosud Khir. 2021;27(3):77-83. doi: 10.33529/ANGIO2021310. Russian.
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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.
Yuriy Stoyko principal investigator
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 Disease, 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 5 inclusion and 26 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 13 Jan 2023. 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 13 Jan 2023). 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?
Dynamics of the Main Veno-specific Symptoms, Assessed by Visual Analog Scale (VAS) - Visit 0 vs Visit4 (time frame: 3 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 NCT03722836, which also lists 1 linked publication.
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 13 Jan 2023.