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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Varicose Veins

Intervention / Treatment
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* Drug: Varisolve (Polidocanol Endovenous Microfoam)
* Drug: Agitated Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Varisolve (polidocanol endovenous mircofoam) | Drug: Varisolve (Polidocanol Endovenous Microfoam)<br>* 1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2)<br>|
| Placebo Comparator: 2<br>Agitated saline | Drug: Agitated Saline<br>* 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks | The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = [(Raw Score) - 5] * 4. | Baseline to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Varicose Veins