Chronic Venous Insufficiency (CVI) Clinical Trial
Official title:
Efficacy on Volume Reduction and Tolerance of Progressiv' Medical Compressive Therapy (MCT) V0322 BC in Patients With Chronic Venous Oedema. International, Multicentric, Randomised, Controlled, Double Blind Study, in Two Parallel Groups v0322 bc Versus Placebo
Elastic MCT is a widely recognized and the consensus-approved treatment for chronic venous
insufficiency (CVI).Efficacy evidence level is often insufficient (grade B or C), or based
on studies carried prior to CEAP classification (2004). Item C3 of this classification
relates to patients suffering from chronic venous disease and permanent oedema. Literature
mentions only one study in which volume reduction in venous-induced oedema was primary
endpoint. Indeed, 240 patients showed a 46.7 ± 8.2 ml reduction (SEM) after 12 weeks with a
Class 2 compression sock (15-20 mm Hg at ankle). Volume is an accurate and reproducible
quantitative measure considered nowadays as being gold standard when objectifying oedema
variation. It is therefore particularly relevant in a C3-patient trial (CEAP
classification).
The main objective of the current study is to evaluate the clinical effect of Progressiv'
MCT on volume reduction in permanent CVI-oedema after 3 months of treatment.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04225806 -
Investigation of Femoropopliteal In Situ Valve Formation With the InterVene System - INFINITE-US
|
N/A |