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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. -

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021270-11-FR

Enrollment

300

Registered

2010-09-03

Start date

2010-09-30

Completion date

Unknown

Last updated

2017-05-08

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

Conditions

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

Interventions

Trade Name: DAFLON 500 mg Product Name: Micronized purified flavonoid fraction Product Code: S05682 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Micronized purified flavonoid fraction

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
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 : - Hemodynamic and anatomic measurements by Duplex ultrasound examination: reflux of the great saphenous vein and at the saphenofemoral junction. - 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.	—

Measure

Time frame

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 : - Hemodynamic and anatomic measurements by Duplex ultrasound examination: reflux of the great saphenous vein and at the saphenofemoral junction. - 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.

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026