Chronic VEnous dIsorders maNagement and Treatment effectivenesS evaluaTion in Chronic vEnous Disease, an International Program

Chronic Venous Disease Clinical Trial

— VEIN STEP  

Official title:

A Prospective, Observational (Non-interventional), International Study to Assess Effectiveness of Conservative Treatments in Chronic Venous Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04574375
• Other study ID #: DIM-05682-007-INT
• Status: Completed
• Start date: June 15, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: December 2022
• Source: Servier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6419
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years old

• Patient consulting spontaneously or referred for symptomatic venous disorders

• Diagnosis of chronic venous disease according to investigator's judgment

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

Related Conditions & MeSH terms

• Chronic Venous Disease

Locations

Country	Name	City	State
France	Servier Affaires Medicales	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Servier Affaires Médicales

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global leg symptoms severity	Measured by visual analogue scale (VAS) and questioning with 4 points rate	week 4
Primary	Global improvement	Measured by Patient Global Impression of Change (PGIC) scale, and time to improvement.	Week 4
Primary	Disease severity	Measured by VCSS (Venous Clinical Severity score)	Week 4
Primary	Quality of Life	Measured by CIVIQ-14 questionnaire	Week 4

External Links

•   Publication with results from MORROCO
•   VEIN STEP: A Prospective, Observational, International Study to Assess Effectiveness of Conservative Treatments in Chronic Venous Disease (in Advances in Therapy, September 2023)