Chronic Venous Disease clinical trial begins in France
The research company Servier Affaires Médicales is conducting the clinical trial of chronic venous disorders management and treatment effectiveness evaluation in Chronic Venous Disease (International Program VEIN STEP).
The primary objective of this study is to assess in real-life settings the effectiveness of conservative treatments on symptoms, signs and quality of life, in patients consulting for CVD.
It is planned to include 6500 participants.
Actual study start date is June 25, 2020. The researchers expect to complete the study by June 2021.
One primary outcome measure is Quality of Life, which will be measured by CIVIQ-14 questionnaire.
Among study population are male and female patients consulting spontaneously or referred for symptomatic CVD not requiring surgical treatment.
Diagnosis of chronic venous disease according to investigator's judgment is included the inclusion criteria.
There are such exclusion criteria:
- Presence of known severe systemic disease likely to interfere with the study evaluation;
- Patients with lower limb arterial disease;
- Patient with any other concomitant disease or treatment that may interfere with lower limb pain or edema;
- Patient consulting for an emergency not related to venous disease;
- Patient currently taking any treatment for chronic venous disorders, either with venoactive drug or with compression hosiery;
- Procedure or surgery for venous disease planned during the study;
- Pregnant or breastfeeding woman.
The location of the study is as follows:
Suresnes, France.
