NCT01402921

Efficacy on Volume Reduction and Tolerance of Progressiv' Medical Compressive Therapy (MCT) V0322 BC in Patients With Chronic Venous Oedema

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Venous Insufficiency (CVI)

Interventions

Type	Name	Description
DEVICE	V0322 BC	* Stocking 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). * The medical device is defined by the following parameters: ankle pressure(10 mmHg)and calf pressure (23 mmHg) * 3 months duration daily treatment

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-01-01
• Completion: 2012-03-01
• First posted: 2011-07-26
• Last updated: 2016-11-10

Locations

1 site across 1 country: France