Impact of Daflon 500 mg on the progression of chronic venous disease and symptoms in patients operated on for varicose veins with conservation of the great saphenous vein. A multicentre, double blind randomised, placebo controlled, parallel group study.

Phase 1

Conditions: Patients suffering from chronic venous disease and for whom ASVAL (Ambulatory Selective Varicose veins Ablation Local anesthesia) surgery is indicated.
MedDRA version: 12.1Level: LLTClassification code 10066682Term: Chronic venous insufficiency

Registration Number: EUCTR2010-021270-11-FR

Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

- Outpatients
- Men and women
- Between the ages of 18-85 inclusive
- Patients suffering from chronic venous disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnant or breastfeeding women

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of Daflon®500 mg (1000 mg per day) on the progression of chronic venous disease and symptoms after surgical treatment of varicose veins by phlebectomy with conservation of the great saphenous vein (ASVAL method).;Secondary Objective: NA;Primary end point(s): To evaluate the efficacy of Daflon 500 mg through :<br>- Hemodynamic and anatomic measurements by Duplex ultrasound examination:<br>reflux of the great saphenous vein and at the saphenofemoral junction.<br>- Other measurements: ankle circumference (Leg-O-Meter), symptoms of chronic venous disease, quality of life, venous clinical severity score, cosmetic improvement and ecchymosis evaluation, and varicose reservoir assessment.<br><br>

Secondary Outcome Measures