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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Varicose Veins

Intervention / Treatment
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* Drug: Polidocanol injectable foam (PEM)
* Drug: Placebo Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polidocanol injectable foam 0.125%<br>Polidocanol injectable foam 0.125% | Drug: Polidocanol injectable foam (PEM)<br>* Injection of Polidocanol injectable foam<br>|
| Experimental: Polidocanol injectable foam 0.5%<br>Polidocanol injectable foam 0.5% | Drug: Polidocanol injectable foam (PEM)<br>* Injection of Polidocanol injectable foam<br>|
| Experimental: Polidocanol injectable foam 1.0%<br>Polidocanol injectable foam 1.0% | Drug: Polidocanol injectable foam (PEM)<br>* Injection of Polidocanol injectable foam<br>|
| Experimental: Polidocanol injectable foam 2.0%<br>Polidocanol injectable foam 2.0% | Drug: Polidocanol injectable foam (PEM)<br>* Injection of Polidocanol injectable foam<br>|
| Placebo Comparator: Vehicle<br>Injection of vehicle comparator | Drug: Placebo Vehicle<br>* Placebo vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) | The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level of activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINESQOL/ Sym items that have been determined in earlier studies to be most important to patients (heaviness, achiness, swelling, throbbing, and itching). The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25, with the lower end of the range being an indicator of less symptom intensity, and the higher end being an indicator of higher intensity). At Visit 2/baseline, Week 8, scores were calculated | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) | The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from Not at all noticeable (a score of 0) to Extremely noticeable (a score of 4). | 8 weeks | 
| Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance | The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 3 trained, blinded clinicians evaluated the appearance of the patient's visible varicose veins using the IPR-V3 instrument's 5-point scale (where 0=none to 4=very severe visible varicose veins). | 8 weeks post treatment | 

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