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Sponsored by: |
University Hospital, Grenoble |
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Information provided by: | University Hospital, Grenoble |
ClinicalTrials.gov Identifier: | NCT00348764 |
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.
Condition | Intervention | Phase |
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Venous Insufficiency Saphenous Vein |
Drug: lauromacrogol |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Treatment of Greater Saphenous Vein (GSV) Insufficiency Using Echo-Guided Sclerotherapy With Lauromacrogol 400 Foam –Comparative Study of 3% Versus 1% Concentration. |
Estimated Enrollment: | 150 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | December 2006 |
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.
Ages Eligible for Study: | 25 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Center of Vascular Medecine - 7 rue Lesdiguières | |
Grenoble, France, 38000 |
Principal Investigator: | DIAMAND Jean Marc | Institut National de la Santé Et de la Recherche Médicale, France |
Study ID Numbers: | DCIC 03 38 |
Study First Received: | July 5, 2006 |
Last Updated: | July 5, 2006 |
ClinicalTrials.gov Identifier: | NCT00348764 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
lauromacrogol Sclerotherapy |
Venous Insufficiency Vascular Diseases Polidocanol |
Venous Insufficiency Vascular Diseases Cardiovascular Diseases |