Clincosm LogoSign in Get a demo

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

Sponsor
Servier Affaires Médicales (Industry)
Overall Status
Completed
CT.gov ID
NCT04574375
Collaborator
(none)
6,419
Enrollment
1
Location
21.5
Actual Duration (Months)
298.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    6419 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective, Observational (Non-interventional), International Study to Assess Effectiveness of Conservative Treatments in Chronic Venous Disease
    Actual Study Start Date :
    Jun 15, 2020
    Actual Primary Completion Date :
    Mar 31, 2022
    Actual Study Completion Date :
    Mar 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Global leg symptoms severity [week 4]

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

    2. Global improvement [Week 4]

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

    3. Disease severity [Week 4]

      Measured by VCSS (Venous Clinical Severity score)

    4. Quality of Life [Week 4]

      Measured by CIVIQ-14 questionnaire

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Servier Affaires Medicales Suresnes France 92284

    Sponsors and Collaborators

    • Servier Affaires Médicales

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Servier Affaires Médicales
    ClinicalTrials.gov Identifier:
    NCT04574375
    Other Study ID Numbers:
    • DIM-05682-007-INT
    First Posted:
    Oct 5, 2020
    Last Update Posted:
    May 4, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Servier Affaires Médicales
    observationnal
    QoL

    Study Results

    No Results Posted as of May 4, 2022