NCT03722836

Evaluation of the Efficacy and Tolerability of Detralex in Patients With Chronic Venous Edema in Real Clinical Practice

Multicenter Observational Program Evaluation of the Efficacy and Tolerability of Detralex Treatment in Patients With Chronic Venous Edema (CEAP Class С3) in Real Clinical Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 708 (actual)
• Sponsor: Servier Russia · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: —

Summary

The VAP-PRO-C3 is a multicenter observational program, which is carried out in the frame of routine consultations and follow-up of patients. The program includes patients with chronic venous diseases (CVDs) of CEAP class C3. It is scheduled in Russia for 2018-2019. The program is expected to enroll 90 phlebologists from 60 cities of Russia. The planned number of patients is 900

Detailed description

The study is aimed at evaluating the efficacy and safety of systemic pharmacotherapy (Detralex) as a part of combination treatment, and its influence on the general outcomes of treatment of patients with chronic venous edema (CEAP class C3) in real clinical practice. Each investigator is planned to include in the program 10 patients fulfilling the inclusion criteria. The treatment will be carried out in accordance to the routine clinical practice, instructions for the medical use of drugs, and a specific clinical situation. To assess changes in edema, the method of truncated cones and duplex ultrasound scanning (DUS) will be used.

Conditions

• Chronic Venous Disease

Timeline

• Start date: 2018-12-06
• Primary completion: 2019-06-15
• Completion: 2019-06-20
• First posted: 2018-10-29
• Last updated: 2023-01-13
• Results posted: 2023-01-13

Locations

1 site across 1 country: Russia