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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04574375
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Servier ( Servier Affaires Médicales )

Study Description
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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
Chronic Venous Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 7000 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 : June 15, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Global leg symptoms severity [ Time Frame: week 4 ]
    Measured by visual analogue scale (VAS) and questioning with 4 points rate

  2. Global improvement [ Time Frame: Week 4 ]
    Measured by Patient Global Impression of Change (PGIC) scale, and time to improvement.

  3. Disease severity [ Time Frame: Week 4 ]
    Measured by VCSS (Venous Clinical Severity score)

  4. Quality of Life [ Time Frame: Week 4 ]
    Measured by CIVIQ-14 questionnaire


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients consulting spontaneously or referred for symptomatic CVD not requiring surgical treatment
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04574375


Contacts
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Contact: Valérie Lehner (33)1 55 72 60 00 valerie.lehner@servier.com

Locations
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France
Servier Affaires Medicales Recruiting
Suresnes, France, 92284
Sponsors and Collaborators
Servier Affaires Médicales
More Information
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Responsible Party: Servier Affaires Médicales
ClinicalTrials.gov Identifier: NCT04574375    
Other Study ID Numbers: DIM-05682-007-INT
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Servier ( Servier Affaires Médicales ):
observationnal
QoL