NCT04138576

Efficacy and Tolerability of Venoactive Drugs in Patients With Chronic Venous Diseases C4a&b in Real Clinical Practice.

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 381 (actual)
• Sponsor: Servier Russia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: * 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). 2. To evaluate the changes in the quality of life using the CIVIQ-14 questionnaire (global index score \[GIS\]) . 3. 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

Timeline

• Start date: 2019-12-25
• Primary completion: 2020-10-01
• Completion: 2020-12-01
• First posted: 2019-10-24
• Last updated: 2023-09-01
• Results posted: 2023-09-01

Locations

1 site across 1 country: Russia