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

October 3, 2023 updated by: Servier Affaires Médicales

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

6419

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92284
        • Servier Affaires Medicales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Servier Affaires Médicales

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 3, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DIM-05682-007-INT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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