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

NCT ID: NCT04574375

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

6419 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-15

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Venous Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Servier Affaires Médicales

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Servier Affaires Medicales

Suresnes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Mezalek ZT, Feodor T, Chernukha L, Chen Z, Rueda A, Sanchez IE, Ochoa AJG, Chirol J, Blanc-Guillemaud V, Lohier-Durel C, Ulloa JH. VEIN STEP: A Prospective, Observational, International Study to Assess Effectiveness of Conservative Treatments in Chronic Venous Disease. Adv Ther. 2023 Nov;40(11):5016-5036. doi: 10.1007/s12325-023-02643-6. Epub 2023 Sep 20.

Reference Type DERIVED
PMID: 37728696 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://link.springer.com/article/10.1007/s12325-023-02643-6

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DIM-05682-007-INT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.