Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence

Inclusion Criteria:

• Males and Females 18-65 years old
• VEINES Sym Score less than 75 points
• Varicose Vein clinical classification CEAP 2, 3, 4, or 5
• Incompetence of SFJ associated with incompetence of the GSV or other major accessoryvein
• Superficial venous disease manifested by both symptoms and visible varicosities
• Ability to comprehend and sign an informed consent document and completed studyquestionnaires in English

Exclusion Criteria:

• Incompetence of the SSV which substantially contributes to the filling of visiblevaricose veins
• Current or previous Deep Vein Thrombosis
• Leg obesity
• Peripheral arterial disease in the leg to be treated
• Reduced mobility
• Planned prolonged travel with limited mobility with in 4 weeks of treatment
• History of pulmonary embolism or stroke
• Major surgery, prolonged hospitalization or pregnancy within 3 months
• Current anticoagulation therapy (within 7 days of enrollment)
• Participation in a clinical study involving a investigational product within 3 months
• Major co-existing disease or clinically significant laboratory abnormalities
• Known allergic response to polidocanol or heparin or severe and/or multiple allergicreactions
• Women of childbearing potential not using effective contraception one month prior toenrollment and/or unwilling to continue while on study
• Pregnant or lactating women
• Current alcohol or drug abuse