Conditions: Great Saphenous Vein Incompetence Visible Varicosities
Keywords: varicose veins Great saphenous vein varicosities
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 117
Healthy volunteers: no

Brief summary:
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) when used following an approved heat treatment in subjects with varicose veins.

Detailed description:

Arms:
arm 1: Endovenous ablation followed by an injection of polidocanol injectable microfoam 0.125% to target vein arm 2: Endovenous ablation followed by injection of polidocanol injectable microfoam, 1.0% to the target vein arm 3: endovenous ablation followed by injection of vehicle (placebo) to target vein

Interventions: intervention 1: endovenous ablation+polidocanol injectable microfoam 0.125% intervention 2: Endovenous ablation+polidocanol injectable microfoam 1.0% intervention 3: Endovenous ablation+polidocanol injectable foam 2.0%
Intervention descriptions: intervention 1: All components except API intervention 2: endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0% intervention 3: Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%

Protocol document: