Venous Insufficiency Clinical Trial
Official title:
Treatment of Greater Saphenous Vein (GSV) Insufficiency Using Echo-Guided Sclerotherapy With Lauromacrogol 400 Foam –Comparative Study of 3% Versus 1% Concentration.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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