Clinical trial NCT00758420: Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence
Official title: A Randomized, Single Blind, Placebo Controlled, Multicenter Study to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for the Treatment of Symptomatic, Visible Varicose Veins With Saphenofemoral Junction (SFJ) Incompetence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Varicose Veins
Keywords: Varicose Veins
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The purpose of this study is to evaluate the efficacy of polidocanol injectable foam vs placebo treatments in relief of symptoms using two disease specific questionnaires, establishment of a minimally important difference (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 polidocanol injectable foam 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.

Eligibility 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

Primary outcomes:
measure: The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks
timeFrame: Baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Bellevue
country: United States
state: Washington
Study officials:
affiliation: BTG International Inc.
name: Janet Rush, MD
role: STUDY_CHAIR
References:
citation: Gibson K, Kabnick L; Varithena(R) 013 Investigator Group. A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of Varithena(R) (polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence. Phlebology. 2017 Apr;32(3):185-193. doi: 10.1177/0268355516635386. Epub 2016 Jul 9.