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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Scientific Corporation; BTG International Inc.
• Treatments: Polidocanol

Criteria

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 heparin 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