Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

Completed · Phase 3 · Has a placebo group

Conditions studied: Varicose Veins

In brief

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 three different concentrations of an investigational drug, polidocanol injectable foam compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

Key facts

Study ID

NCT01072877

Run by

Boston Scientific Corporation

People needed

279

Starts

2010-12-01

Expected to finish

2012-11-01

Last updated by the study team

2021-04-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
• Ability to comprehend and sign an informed consent document and complete study questionnaires in English
• Ability to record symptoms in accordance with the protocol
• Symptomatic varicose veins
• Visible varicose veins

You may not qualify if…

• Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP (clinical, etiologic, anatomic, and pathophysiologic) Classification of Venous Disorders).
• Leg obesity impairing the ability to access the vein to be treated and/or to apply postprocedure compression bandaging and stockings
• Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion
• Deep vein reflux unless clinically insignificant in comparison to superficial reflux
• Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
• Reduced mobility
• Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
• Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)
• Known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions
• Current alcohol or drug abuse
• Pregnant or lactating women
• Women of childbearing potential not using effective contraception
• History of DVT, pulmonary embolism or stroke

Where it is running

• Study site — Laguna Hills, California, United States
• Study site — San Diego, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Aventura, Florida, United States
• Study site — Bradenton, Florida, United States
• Study site — Oakbrook Terrace, Illinois, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Hartsdale, New York, United States
• Study site — New York, New York, United States
• Study site — North Tonawanda, New York, United States
• Study site — Stony Brook, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Toledo, Ohio, United States
• Study site — Bend, Oregon, United States
• Study site — Clarksville, Tennessee, United States
• Study site — Kirkland, Washington, United States
• Study site — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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