Clinical trial NCT01072877: Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
Official title: A Randomized, Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Polidocanol Injectable Foam 0.5%, 1.0%, or 2.0% Compared to Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Varicose Veins
Keywords: Varicose Veins
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-02-22
Enrollment: 279
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)
timeFrame: Week 8
Secondary outcomes:
measure: Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)
timeFrame: 8 weeks
measure: Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance
timeFrame: 8 weeks post treatment
Other outcomes:
Locations:
city: Laguna Hills
country: United States
state: California
city: San Diego
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Aventura
country: United States
state: Florida
city: Bradenton
country: United States
state: Florida
city: Oakbrook Terrace
country: United States
state: Illinois
city: Ann Arbor
country: United States
state: Michigan
city: Kalamazoo
country: United States
state: Michigan
city: Hartsdale
country: United States
state: New York
city: New York
country: United States
state: New York
city: North Tonawanda
country: United States
state: New York
city: Stony Brook
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Bend
country: United States
state: Oregon
city: Clarksville
country: United States
state: Tennessee
city: Kirkland
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
Study officials:
References:
citation: King JT, O'Byrne M, Vasquez M, Wright D; VANISH-1 Investigator Group. Treatment of Truncal Incompetence and Varicose Veins with a Single Administration of a New Polidocanol Endovenous Microfoam Preparation Improves Symptoms and Appearance. Eur J Vasc Endovasc Surg. 2015 Dec;50(6):784-93. doi: 10.1016/j.ejvs.2015.06.111. Epub 2015 Sep 16.