Chronic Venous DiseasesVAP-PRO-C4NCT04138576
Efficacy and Tolerability of Venoactive Drugs in Patients With Chronic Venous Diseases C4a&b in Real Clinical Practice.
An observational study of Chronic Venous Diseases, run by Servier Russia at 1 site in Russia.
Trial summary
The study is aimed at evaluating the efficacy and tolerability of systemic pharmacotherapy as a part of combination treatment, and its influence on the overall treatment outcomes in patients with skin changes (CEAP class C4a and C4b). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Diseases
- How many people
- 381 participants
- Where
- 1 siteRussia
- Study dates
- 25 Dec 2019to 1 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic venous diseases of CEAP class C4a and C4b
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 CEAP class C4
- No surgical intervention for CVD is planned by a doctor
Who cannot join
- Chronic venous disease of СЕАР class C0-С3 or class С4-С6
- History of alcohol or drug abuse or use of narcotic drugs
- Peripheral artery disease
- Lymphatic edema of the lower extremities
- Secondary varicose veins, angiodysplasia, or neoplasia
- Arterial disease (ankle-brachial index <0.9)
Show all 17Show fewer
- 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
- Chronic kidney disease
- Decompensated diabetes mellitus
- Skin diseases of non-venous origin
- 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) History of surgical intervention (within the past 3 months) Patient cannot walk (regardless of the cause) Predictable poor adherence to treatment Participation of a 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 Patients with a contraindication to diosmin-containing agents, including Detralex Patient uses the topical treatments contraindicated in case of skin integrity violation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Tolerability of Venoactive Drugs in Combination Therapy and Their Effect on the Overall Treatment Outcomes in Patients With Chronic Venous Diseases of CEAP Class C4a and C4b in Real Clinical Practice.
The study is aimed at evaluating the efficacy and tolerability of systemic pharmacotherapy as a part of combination treatment, and its influence on the overall treatment outcomes in patients with skin changes (CEAP class C4a and C4b).
Read the detailed description
Primary goal:
To study the efficacy of systemic pharmacotherapy as part of combination therapy and its impact on the:
- thickness of the skin-fat fold (ultrasound examination);
- change in the venous clinical severity score (VCSS);
- change in the CEAP clinical class of CVD;
- evolution of CVD symptoms characteristic for CEAP class C4 (sensations of skin tightening, burning, itching, pain, and exudation) using the Visual Analogue Scale (VAS).
Secondary goals:
- To study the efficacy of systemic pharmacotherapy as part of combination therapy and its impact on the:
- area of affected skin determined by curvimetry technique (only in selected centers that use this technique routinely) before and after the treatment in patients with skin changes of CEAP class C4a or C4b in real clinical practice;
- skin density determined by durometry technique (only in selected centers that use this technique routinely).
- To evaluate the changes in the quality of life using the CIVIQ-14 questionnaire (global index score [GIS]) .
- To study the tolerability of systemic pharmacotherapy as part of combination therapy in patients with skin changes of CEAP class C4a or C4b.
- Conditions
- Chronic Venous Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mean Subcutaneous Adipose Tissue Thickness Changes (mm) Between the Visit 3 and Baseline by Ultrasound Examination.
Ultrasound examination was used to get:
- Thickness of the thickness of the skin-fat fold at the affected skin area;
- Presence of reflux or occlusion (with an indication of the terrotiry).
- Measurements should be taken in the afternoon at about the same time, at visits V0 and V3.
- The data are recorded only for the limb with the most severe changes.
- Measurements are taken at the site of skin changes. Unit of Measure - mm
Measured: 6 months
Secondary outcomes (12)
The Mean Changes VCSS for Pain (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale
Was used four-point scale the Venous Clinical Severity Score(VCSS ). It uses a number of clinical signs, which are assigned a point equivalent depending on their severity (pain, varicose veins, edema, hyperpigmentation, inflammation, induration, the number of ulcers, the presence of active ulcers, the use of compression therapy). The sum of points reflects the severity of the pathology: the more points, the more severe the course of chronic venous disease. Changing the amount of points over time allows you to assess the degree of disease progression or the effectiveness of treatment measures.
Measured: 6 months
The Mean Changes VCSS for Hyperpigmentation (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale
Was used four-point scale the Venous Clinical Severity Score(VCSS ). It uses a number of clinical signs, which are assigned a point equivalent depending on their severity (pain, varicose veins, edema, hyperpigmentation, inflammation, induration, the number of ulcers, the presence of active ulcers, the use of compression therapy). The sum of points reflects the severity of the pathology: the more points, the more severe the course of chronic venous disease. Changing the amount of points over time allows you to assess the degree of disease progression or the effectiveness of treatment measures.
Measured: 6 months
The Mean Changes VCSS for Inflammation (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale
Was used four-point scale the Venous Clinical Severity Score(VCSS ). It uses a number of clinical signs, which are assigned a point equivalent depending on their severity (pain, varicose veins, edema, hyperpigmentation, inflammation, induration, the number of ulcers, the presence of active ulcers, the use of compression therapy). The sum of points reflects the severity of the pathology: the more points, the more severe the course of chronic venous disease. Changing the amount of points over time allows you to assess the degree of disease progression or the effectiveness of treatment measures.
Measured: 6 months
Outcome Measure Title: The Mean Changes VCSS for Subcutaneous Tissue Induration (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale
Was used four-point scale the Venous Clinical Severity Score(VCSS ). It uses a number of clinical signs, which are assigned a point equivalent depending on their severity (pain, varicose veins, edema, hyperpigmentation, inflammation, induration, the number of ulcers, the presence of active ulcers, the use of compression therapy). The sum of points reflects the severity of the pathology: the more points, the more severe the course of chronic venous disease. Changing the amount of points over time allows you to assess the degree of disease progression or the effectiveness of treatment measures.
Measured: 6 months
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). -Skin Tightening
Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is designed to measure symptom's intensity. It is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points located on it: "no symptom " and "the strongest symptom you can imagine."
Visual analogue scale technique:
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 worst symptom imaginable," providing a score range of 0 to 100. A higher score indicates more pain intensity.
Measured: 6 months
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Intensity of Burning Sensation
Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is designed to measure symptom's intensity. It is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points located on it: "no symptom " and "the strongest symptom you can imagine."
Visual analogue scale technique:
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 worst symptom imaginable," providing a score range of 0 to 100. A higher score indicates more pain intensity.
Measured: 6 months
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Skin Itching
Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is designed to measure symptom's intensity. It is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points located on it: "no symptom " and "the strongest symptom you can imagine."
Visual analogue scale technique:
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 worst symptom imaginable," providing a score range of 0 to 100. A higher score indicates more pain intensity.
Measured: 6 months
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Pain
Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is designed to measure symptom's intensity. It is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points located on it: "no symptom " and "the strongest symptom you can imagine."
Visual analogue scale technique:
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 worst symptom imaginable," providing a score range of 0 to 100. A higher score indicates more pain intensity.
Measured: 6 months
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Exudation
Visual Analogue Scale (VAS) The Visual Analogue Scale (VAS) is designed to measure symptom's intensity. It is a continuous scale in the form of a horizontal or vertical line 10 cm (100 mm) long with two extreme points located on it: "no symptom " and "the strongest symptom you can imagine."
Visual analogue scale technique:
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 worst symptom imaginable," providing a score range of 0 to 100. A higher score indicates more pain intensity.
Measured: 6 months
The Mean Changes of Global Index CIVIQ-14 Score (GIS) Between the Visit 3 and Baseline Evaluated
CIVIQ-14 - Chronic Venous Insufficiency Questionnaire (CIVIQ-14) is a specific questionnaire for venous disease. It was used to evaluate the changes in the quality of life (global index score - GIS) There are 14 questions in the CIVIQ-14, each with 5 possible answers (1 to 5), the minimum possible score being 14 and the maximum 70. In order to calculate the GIS, the difference between the final score and the minimum possible score is to be divided by the difference between the theoretical maximum and minimum scores (70-14=56), multiplied by 100.
GIS = ([Final score - minimal possible score] / [Theoretical maximal - minimal score]) x 100 GIS = ([Final score - minimal possible score] / 56) x 100 GIS = ([Final score - 14] / 56) x 100 The least GIS corresponds with the best quality of life, the largest GIS corresponds with the worst.
Measured: 6 months
The Mean Lesion Area Changes Between the Visit 3 and Baseline Evaluated by Curvimetry Technique
This technique was used in only in Selected Centers That Use This Technique Routinely:
technique is measured length of the border of modified skin, using a measuring device called a curvimetr.
The quality of treatment is assessed by comparing data on Visit 0 and Visit 3 Measurements are carried out 2 times on Visit 0 and Visit 3 (before and after the treatment) in patients with skin changes of CEAP class C4a or C4b A decrease in the figure value (in centimeters) on Visit 3 vs baseline means a good treatment result.
Measured: 6 months
The Mean Changes of the Skin Density Determined by Durometry Technique Between the Visit 3 and Baseline Evaluated.
Shore Hardness scales is a scale for measuring the hardness of different materials.Total score has a range from 0 (the softest material) to 100 scores (the hardest material). Measurement was performed by Shore durometer (a device for measuring the hardness of a material). The method and scale were proposed by Albert F. Shore.
This technique was used in only in Selected Centers That Use This Technique Routinely:
technique: repeated measures to compare the scores before and after the treatment.
Shore hardness is one of the methods for measuring the hardness of materials. In medicine, it is used to determine the density of the skin. In this study, the method was used to determine the density of the skin in the area of skin lesions in patients with CVD stage C4 (CEAP)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start25 Dec 2019
- Primary completion1 Oct 2020
- Study completion1 Dec 2020
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 (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous DiseasesStudies 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
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Russia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olga Linnik, Study chair, Medical manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138576
- Sponsor's protocol ID
- IC4-05682-059-RUS
- Acronym
- VAP-PRO-C4
- Status last verified
- Oct 2022
- First submitted
- 16 Oct 2019
- Last updated
- 1 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bogachev VY, Boldin BV, Turkin PY, Varich GA, Samenkov AY; VAP-PRO-C4 Study Investigators Group. [Objective control over efficacy of therapy for trophic skin disorders in chronic venous insufficiency of lower limbs]. Angiol Sosud Khir. 2023 Jun 21;29(2):143-149. doi: 10.33029/1027-6661-2023-29-2-143-149. Russian.
PubMed 41776914Bogachev V, Boldin B, Turkin P, Samenkov A, Dzhenina O. Micronized purified flavonoid fraction-based conservative treatment of chronic venous disease in a real-world setting. Future Cardiol. 2022 Sep;18(10):777-785. doi: 10.2217/fca-2022-0026. Epub 2022 Aug 25.
PubMed 36004765
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Tolerability of Venoactive Drugs in Combination Therapy and Their Effect on the Overall Treatment Outcomes in Patients With Chronic Venous Diseases of CEAP Class C4a and C4b in Real Clinical Practice.
- ClinicalTrials.gov ID
- NCT04138576
- Acronym / sponsor ID
- VAP-PRO-C4 / IC4-05682-059-RUS
- Conditions
- Chronic Venous Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Servier RussiaIndustry (pharma, biotech, devices)
- Study start
- 25 Dec 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Posted 1 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is aimed at evaluating the efficacy and tolerability of systemic pharmacotherapy as a part of combination treatment, and its influence on the overall treatment outcomes in patients with skin changes (CEAP class C4a and C4b).
Detailed description
Primary goal:
To study the efficacy of systemic pharmacotherapy as part of combination therapy and its impact on the:
- thickness of the skin-fat fold (ultrasound examination);
- change in the venous clinical severity score (VCSS);
- change in the CEAP clinical class of CVD;
- evolution of CVD symptoms characteristic for CEAP class C4 (sensations of skin tightening, burning, itching, pain, and exudation) using the Visual Analogue Scale (VAS).
Secondary goals:
- To study the efficacy of systemic pharmacotherapy as part of combination therapy and its impact on the:
- area of affected skin determined by curvimetry technique (only in selected centers that use this technique routinely) before and after the treatment in patients with skin changes of CEAP class C4a or C4b in real clinical practice;
- skin density determined by durometry technique (only in selected centers that use this technique routinely).
- To evaluate the changes in the quality of life using the CIVIQ-14 questionnaire (global index score [GIS]) .
- To study the tolerability of systemic pharmacotherapy as part of combination therapy in patients with skin changes of CEAP class C4a or C4b.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic venous diseases of CEAP class C4a and C4b
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 CEAP class C4
- No surgical intervention for CVD is planned by a doctor
Key exclusion criteria (17 listed)
- Chronic venous disease of СЕАР class C0-С3 or class С4-С6
- History of alcohol or drug abuse or use of narcotic drugs
- Peripheral artery disease
- Lymphatic edema of the lower extremities
- Secondary varicose veins, angiodysplasia, or neoplasia
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
The Mean Subcutaneous Adipose Tissue Thickness Changes (mm) Between the Visit 3 and Baseline by Ultrasound Examination.
Time frame: 6 months
Ultrasound examination was used to get: 1. Thickness of the thickness of the skin-fat fold at the affected skin area; 2. Presence of reflux or occlusion (with an indication of the terrotiry). * Measurements should be taken in the afternoon at about the same time, at visits V0 and V3. * The data are recorded only for the limb with the most severe changes. * Measurements are taken at the site of skin changes. Unit of Measure - mm
12 secondary outcomes
The Mean Changes VCSS for Pain (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale
Time frame: 6 months
The Mean Changes VCSS for Hyperpigmentation (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale
Time frame: 6 months
The Mean Changes VCSS for Inflammation (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale
Time frame: 6 months
Outcome Measure Title: The Mean Changes VCSS for Subcutaneous Tissue Induration (Four-point Scale (From 0 to 3)) Between the Visit 3 and Baseline by Ultrasound Examination. Change in the VCSS Scale
Time frame: 6 months
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). -Skin Tightening
Time frame: 6 months
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Intensity of Burning Sensation
Time frame: 6 months
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Skin Itching
Time frame: 6 months
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Pain
Time frame: 6 months
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Exudation
Time frame: 6 months
The Mean Changes of Global Index CIVIQ-14 Score (GIS) Between the Visit 3 and Baseline Evaluated
Time frame: 6 months
The Mean Lesion Area Changes Between the Visit 3 and Baseline Evaluated by Curvimetry Technique
Time frame: 6 months
The Mean Changes of the Skin Density Determined by Durometry Technique Between the Visit 3 and Baseline Evaluated.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41776914Bogachev VY, Boldin BV, Turkin PY, Varich GA, Samenkov AY; VAP-PRO-C4 Study Investigators Group. [Objective control over efficacy of therapy for trophic skin disorders in chronic venous insufficiency of lower limbs]. Angiol Sosud Khir. 2023 Jun 21;29(2):143-149. doi: 10.33029/1027-6661-2023-29-2-143-149. Russian.
- Derived from this study: PubMed 36004765Bogachev V, Boldin B, Turkin P, Samenkov A, Dzhenina O. Micronized purified flavonoid fraction-based conservative treatment of chronic venous disease in a real-world setting. Future Cardiol. 2022 Sep;18(10):777-785. doi: 10.2217/fca-2022-0026. Epub 2022 Aug 25.
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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.
Olga Linnik study chair
Medical manager
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 Diseases, 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 17 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 1 Sep 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 1 Sep 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?
The Mean Subcutaneous Adipose Tissue Thickness Changes (mm) Between the Visit 3 and Baseline by Ultrasound Examination. (time frame: 6 months). 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 NCT04138576, which also lists 2 linked publications.
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 1 Sep 2023.