Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Endovenous Microfoam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence (Pilot)

The purpose of this study is to evaluate the effectiveness of Varisolve in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the treatment of varicose veins compared to placebo.

The purpose of this study is to evaluate the efficacy of Varisolve vs placebo treatments in relief of symptoms using two disease specific questionnaires, establishment of an MID for the questionnaires, improvement in the appearance of visible varicosities by a patient and medical assessments aided by pre and post treatment photographs, and a central independent assessor evaluating pre and post treatment photographs. In addition, the study will evaluate the efficacy of Varisolve vs the placebo treatment in the elimination of SFJ reflux or occlusion of the treated vein, and to determine whether the placebo procedure blinds the patient to treatment assignment.

• Drug: Varisolve (Polidocanol Endovenous Microfoam)
  1% polidocanol, up to 15 mL, one treatment session
• Drug: Agitated Saline
  10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session

• Active Comparator: 1
  Varisolve (polidocanol endovenous mircofoam)
  Intervention: Drug: Varisolve (Polidocanol Endovenous Microfoam)
• Placebo Comparator: 2
  Agitated saline
  Intervention: Drug: Agitated Saline

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 accessory vein
• Superficial venous disease manifested by both symptoms and visible varicosities
• Ability to comprehend and sign an informed consent document and completed study questionnaires in English

Exclusion Criteria:

• Incompetence of the SSV which substantially contributes to the filling of visible varicose 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 severe and/or multiple allergic reactions
• Women of childbearing potential not using effective contraception one month prior to enrollment and/or unwilling to continue while on study
• Pregnant or lactating women
• Current alcohol or drug abuse