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

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

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Key information

Conditions

Chronic Venous Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Servier Affaires Medicales

Suresnes, 92284, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Global leg symptoms severity

Time frame: week 4

Measured by visual analogue scale (VAS) and questioning with 4 points rate
Global improvement

Time frame: Week 4

Measured by Patient Global Impression of Change (PGIC) scale, and time to improvement.
Disease severity

Time frame: Week 4

Measured by VCSS (Venous Clinical Severity score)
Quality of Life

Time frame: Week 4

Measured by CIVIQ-14 questionnaire

Sponsors and collaborators

Lead sponsor

Servier Affaires Médicales

Industry

Registry information

Official study title

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

Acronym: VEIN STEP

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Oct 5, 2020
Registry last updated: Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed