18 and older, any sex, with Chronic Venous Diseases. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Mean Subcutaneous Adipose Tissue Thickness Changes (mm) Between the Visit 3 and Baseline by Ultrasound Examination.Primary· 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
Group
Value
95% CI
Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice
2.5
± 4.5
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 ScaleSecondary· 6 months
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.
Group
Value
95% CI
Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice
0.74
± 0.68
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 ScaleSecondary· 6 months
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.
Group
Value
95% CI
Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice
0.49
± 0.74
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 ScaleSecondary· 6 months
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.
Group
Value
95% CI
Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice
0.45
± 0.74
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 ScaleSecondary· 6 months
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.
Group
Value
95% CI
Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice
0.36
± 0.71
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). -Skin TighteningSecondary· 6 months
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
Group
Value
95% CI
Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice
2.63
± 2.41
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Intensity of Burning SensationSecondary· 6 months
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
Group
Value
95% CI
Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice
2.40
± 2.40
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Skin ItchingSecondary· 6 months
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
Group
Value
95% CI
Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice
2.66
± 2.42
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - PainSecondary· 6 months
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
Group
Value
95% CI
Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice
2.90
± 2.33
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - ExudationSecondary· 6 months
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
Group
Value
95% CI
Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice
0.48
± 1.45
The Mean Changes of Global Index CIVIQ-14 Score (GIS) Between the Visit 3 and Baseline EvaluatedSecondary· 6 months
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 = (\[Final score - minimal possible score\]
Group
Value
95% CI
Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice
22.4
± 16.5
The Mean Lesion Area Changes Between the Visit 3 and Baseline Evaluated by Curvimetry TechniqueSecondary· 6 months
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.
Group
Value
95% CI
Patients With CVD of CEAP Classes C4a and C4b Included in Curvimetry Technique Group
6.9
± 13.4
Sponsor's own description
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).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Servier Russia
Last refreshed: 1 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04138576.