Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-08-31

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 Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.

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Detailed Description

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Conditions

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Varicose Veins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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polidocanol injectable foam, 0.125%

Group Type EXPERIMENTAL

polidocanol injectable foam, 0.125%

Intervention Type DRUG

active placebo for blinding

polidocanol injectable foam, 0.5%

Group Type EXPERIMENTAL

polidocanol injectable foam, 0.5%

Intervention Type DRUG

0.5% polidocanol foam injection

polidocanol injectable foam, 1.0%

Group Type EXPERIMENTAL

polidocanol injectable foam, 1.0%

Intervention Type DRUG

1.0% polidocanol foam injection

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

injection of vehicle comparator

Interventions

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polidocanol injectable foam, 0.125%

active placebo for blinding

Intervention Type DRUG

polidocanol injectable foam, 0.5%

0.5% polidocanol foam injection

Intervention Type DRUG

polidocanol injectable foam, 1.0%

1.0% polidocanol foam injection

Intervention Type DRUG

Vehicle

injection of vehicle comparator

Intervention Type DRUG

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 Classification of Venous Disorders).
* Leg obesity impairing the ability to access the vein to be treated and/or to apply post-procedure 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No