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

NCT04574375 | Completed

• 1 other identifier: DIM-05682-007-INT
• Study Type: observational
• Target: 6,419
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Venous Disease

Keywords

observationnal; QoL

Outcome Measures

Primary Outcomes (4)

• Global leg symptoms severity

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

  week 4

• Global improvement

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

  Week 4

• Disease severity

  Measured by VCSS (Venous Clinical Severity score)

  Week 4

• Quality of Life

  Measured by CIVIQ-14 questionnaire

  Week 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients consulting spontaneously or referred for symptomatic CVD not requiring surgical treatment

You may qualify if:

• Age ≥18 years old
• Patient consulting spontaneously or referred for symptomatic venous disorders
• Diagnosis of chronic venous disease according to investigator's judgment

You may not qualify if:

• 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

Sponsors & Collaborators

• Servier Affaires Médicales: lead

Study Sites (1)

Servier Affaires Medicales

Suresnes, 92284, France

Location

Related Publications (1)

• 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.

  PMID: 37728696 DERIVED

Related Links

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 5, 2020
• Study Start: June 15, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: October 6, 2023

Record last verified: 2022-12

Locations

FR (1)