Trial Outcomes & Findings for Efficacy and Tolerability of Venoactive Drugs in Patients With Chronic Venous Diseases C4a&b in Real Clinical Practice. (NCT NCT04138576)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

381 participants

Primary outcome timeframe

6 months

Results posted on

2023-09-01

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice The study enrolled adults (≥18 years old) with CVD of CEAP class C4 (a or b) severity whose physicians recommended the initiation of MPFF (1000 mg/day) in addition to conservative treatment according to routine clinical practice, and for whom surgical intervention for their CVD was not currently planned
Overall Study STARTED	381
Overall Study COMPLETED	365
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice The study enrolled adults (≥18 years old) with CVD of CEAP class C4 (a or b) severity whose physicians recommended the initiation of MPFF (1000 mg/day) in addition to conservative treatment according to routine clinical practice, and for whom surgical intervention for their CVD was not currently planned
Overall Study Due to epidemiological situation (COVID-19) patients were dropped out from the study.	16

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice n=365 Participants According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema.
Age, Categorical <=18 years	0 Participants n=365 Participants
Age, Categorical Between 18 and 65 years	269 Participants n=365 Participants
Age, Categorical >=65 years	96 Participants n=365 Participants
Age, Continuous	59.24 years STANDARD_DEVIATION 11.30 • n=365 Participants
Sex: Female, Male Female	239 Participants n=365 Participants
Sex: Female, Male Male	126 Participants n=365 Participants
Region of Enrollment Russia	365 participants n=365 Participants
Patients with chronic venous diseases of CEAP classes C4a and C4b in real clinical practice	365 Participants n=365 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice n=365 Participants According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema.
The Mean Subcutaneous Adipose Tissue Thickness Changes (mm) Between the Visit 3 and Baseline by Ultrasound Examination.	2.5 mm Standard Deviation 4.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice n=365 Participants According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema.
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	0.74 point on scale Standard Deviation 0.68

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice n=365 Participants According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema.
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	0.49 point on scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice n=365 Participants According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema.
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	0.45 point on scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice n=365 Participants According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema.
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	0.36 point on scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: 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. A higher score indicates more pain intensity.

Outcome measures

Outcome measures
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice n=365 Participants According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema.
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). -Skin Tightening	2.63 point on scale Standard Deviation 2.41

SECONDARY outcome

Timeframe: 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. A higher score indicates more pain intensity.

Outcome measures

Outcome measures
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice n=365 Participants According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema.
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Intensity of Burning Sensation	2.40 point on scale Standard Deviation 2.40

SECONDARY outcome

Timeframe: 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. A higher score indicates more pain intensity.

Outcome measures

Outcome measures
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice n=365 Participants According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema.
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Skin Itching	2.66 point on a scale Standard Deviation 2.42

SECONDARY outcome

Timeframe: 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. A higher score indicates more pain intensity.

Outcome measures

Outcome measures
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice n=365 Participants According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema.
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Pain	2.90 point on a scale Standard Deviation 2.33

SECONDARY outcome

Timeframe: 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. A higher score indicates more pain intensity.

Outcome measures

Outcome measures
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice n=365 Participants According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema.
The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Exudation	0.48 point on a scale Standard Deviation 1.45

SECONDARY outcome

Timeframe: 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 = (\[Final score - minimal possible score\] / \[Theoretical maximal - minimal score\]) 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.

Outcome measures

Outcome measures
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice n=365 Participants According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema.
The Mean Changes of Global Index CIVIQ-14 Score (GIS) Between the Visit 3 and Baseline Evaluated	22.4 Global Index CIVIQ-14 Score Standard Deviation 16.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice n=60 Participants According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema.
The Mean Lesion Area Changes Between the Visit 3 and Baseline Evaluated by Curvimetry Technique	6.9 centimeter Standard Deviation 13.4

SECONDARY outcome

Timeframe: 6 months

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)

Outcome measures

Outcome measures
Measure	Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice n=55 Participants According to the international CEAP classification, chronic venous diseases of clinical class C4 are characterized by various changes of skin and subcutaneous tissue of the affected limbs. They include skin hemosiderosis, Milian's white atrophy, indurative cellulitis, lipodermatosclerosis, and varicose eczema.
The Mean Changes of the Skin Density Determined by Durometry Technique Between the Visit 3 and Baseline Evaluated.	3.9 scores on a scale Standard Deviation 9.3

Adverse Events

Patients With Chronic Venous Diseases of CEAP Classes C4a and C4b in Real Clinical Practice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Medical Manager-Olga Linnik

ServierRussia

Phone: 8-495-93707-00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place