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Clinical Trials/NCT04138576
NCT04138576CompletedNot Applicable

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.

Servier Russia1 site in 1 country381 target enrollmentStarted: December 25, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
381
Locations
1
Primary Endpoint
The Mean Subcutaneous Adipose Tissue Thickness Changes (mm) Between the Visit 3 and Baseline by Ultrasound Examination.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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).

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:

  1. To study the efficacy of systemic pharmacotherapy as part of combination therapy and its impact on the:

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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)
  • •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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). -Skin Tightening(6 months)
  • 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(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(6 months)
  • The Mean Changes of Global Index CIVIQ-14 Score (GIS) Between the Visit 3 and Baseline Evaluated(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(6 months)
  • The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Pain(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(6 months)
  • The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Skin Itching(6 months)
  • The Mean Changes of the Skin Density Determined by Durometry Technique Between the Visit 3 and Baseline Evaluated.(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(6 months)
  • The Mean Lesion Area Changes Between the Visit 3 and Baseline Evaluated by Curvimetry Technique(6 months)
  • The Mean CVD Symptoms Characteristic Changes Between the Visit 3 and Baseline Evaluated by Means of Visual Analogue Scale (VAS). - Exudation(6 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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