Chronic VEnous dIsorders maNagement & Treatment NCT04574375

Updated 06/21/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT04574375
Other study ID #	DIM-05682-007-INT
Secondary ID
Status	Completed
Phase
First received
Last updated
Start date	June 15, 2020
Est. completion date	March 31, 2022

Study information
Verified date	December 2022
Source	Servier
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial 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

Recruitment information / eligibility
Status	Completed
Enrollment	6419
Est. completion date	March 31, 2022
Est. primary completion date	March 31, 2022
Accepts healthy volunteers	No
Gender	All
Age group	18 Years and older
Eligibility	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 Design

Related Conditions & MeSH terms

Chronic Venous Disease

Locations
Country	Name	City	State
France	Servier Affaires Medicales	Suresnes

Sponsors *(1)*
Lead Sponsor	Collaborator
Servier Affaires Médicales

Country where clinical trial is conducted

France,

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

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT00766974` - Compression Aided Management of Edema in Patients With C3 Venous Disease	Phase 4
	Recruiting	`NCT05005052` - Sulodexide in the Treatment of Chronic Primary Venous Disease of the Lower Extremities	Phase 3
	Completed	`NCT04101201` - Clinical Trial to Assess the Efficacy of µSmin® Plus	N/A
	Not yet recruiting	`NCT04901845` - VEIN Health - CVD Prevalence and Characteristics
	Completed	`NCT01801891` - Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers	Phase 2
	Not yet recruiting	`NCT06318988` - Outcomes of Different Treatment Options in Chronic Venous Disease
	Completed	`NCT04310280` - Effects of Local Insulin on Varicose Ulcers for Wound Healing	Phase 3
	Recruiting	`NCT04882228` - Phase 4 Study to Evaluate Efficacy and Safety of Entelon Tab.150mg in Patients With Chronic Venous Disease(CVD)	Phase 4
	Completed	`NCT03722836` - Evaluation of the Efficacy and Tolerability of Detralex in Patients With Chronic Venous Edema in Real Clinical Practice
	Not yet recruiting	`NCT05612217` - Evaluation of the AIVARIX in Detecting Signs C 1-2 Classes of CVD
	Completed	`NCT02137499` - Venous Insufficiency and Neuromuscular Stimulation	N/A

External 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)