A Phase 3 interventional study of lauromacrogol in Venous Insufficiency and Saphenous Vein, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2006-07-06.
Sponsored by University Hospital, Grenoble · Phase 3, Interventional, and Treatment
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.
189 studies on the registry are indexed under Venous Insufficiency; 16 are open to participants now.
This study's enrollment of 150 is above the median of 60 across 139 interventional studies indexed under Venous Insufficiency.
Browse Venous Insufficiency studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of "sus gonal" saphenous reflux > 1 second.
Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of "sus gonal" saphenous reflux > 1 second.
This study is completed, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble