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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04574375

Acronym

VEIN STEP

Enrollment

6419

Registered

2020-10-05

Start date

2020-06-15

Completion date

2022-03-31

Last updated

2023-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Venous Disease

Keywords

observationnal, QoL

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Outcome results