ESGVS: Sclerotherapy With Lauromacrogol

Study Overview
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Brief Summary
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To evaluate the efficacy and the tolerance of echoguided sclerotherapy using Lauromacrogol 400 foam for the treatment of Great Saphenous Vein (GSV) insufficiency. A comparative study of 3% versus 1% Lauromacrogol 400 foam.

Detailed Description
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A multicenter randomized double blind study to evaluate the efficacy and the tolerance of echoguided sclerotherapy using 3% versus 1% Lauromacrogol 400 foam in the treatment of Great Saphenous Vein (GSV) insufficiency. One hundred fifty eligible patients will be recruited during 6 months from 9 study centers with a follow up period of 3 years and 7 visits at day 8, 6 weeks, 3 months, 6 months, 1,2 ,and 3 years. After randomization, the patients will be treated by echoguided sclerotherapy with 1% or 3% Lauromacrogol 400 foam (ratio 1:1). Monitoring is performed by doppler at 8 days, 6 weeks, 6 months , 1,2 ,and 3 years. Effectiveness of sclerotherapy is determined at 6 weeks, 3 months and 6 months. A additional injection of 4 ml of foam can be performed if needed. Severity clinical score and Quality-of-life questionnaire are performed at 6 months ,1 ,2, and 3 years. The absence of obliteration with a reflux of crural great saphenous vein at 6 months will be a criterion of therapeutic failure. The therapeutic success or failure criteria are evaluated by a non investigator angiologist for 5 patients randomized from each investigational site at 1, 2 and 3 years.

Official Title
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Treatment of Greater Saphenous Vein (GSV) Insufficiency Using Echo-Guided Sclerotherapy With Lauromacrogol 400 Foam -Comparative Study of 3% Versus 1% Concentration.

Conditions
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Venous Insufficiency, Saphenous Vein

Intervention / Treatment
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* Drug: lauromacrogol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 25 - 75 years Hawaii CEAP classification : C2-5 Ep, As2-3 Pr Clinical Varicose veins C2, Edema C3, Skin changes C4, Healed ulcer C5 Etiology Ep Primary GSV insufficiency As2-3: Ostial and or crural truncular GVS incompetence Maximal inferior diameter of the leg GSV (patient in decubitus) between 4 and 8mm Pr: reflux by echo doppler in orthostatism > 1 second Information consent form signed by the investigator and the patient. Exclusion Criteria: deep venous reflux (CEAP: Ad) Short saphenous vein or non saphenous network insufficiency (CEAP: A4-5) Clinical class: C1 or C6 Recurrent GSV varicose veins after stripping Thrombophilia or antecedent of deep vein thrombosis Psychiatric disorders Known allergy to Lauromacrogol or to one of its component Arteriopathy. (IPS < 0.8) Post-thrombotic disease Chronic hepatoma Renal insufficiency (creatinine > 150 micromol/l)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: lauromacrogol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of sus gonal saphenous reflux > 1 second. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of sus gonal saphenous reflux > 1 second. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lauromacrogol, Sclerotherapy