Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
Condition: Varicose Veins
MeSH terms: Varicose Veins
Intervention: polidocanol injectable foam, 0.125%; polidocanol injectable foam, 0.5%; polidocanol injectable foam, 1.0%; Vehicle
Intervention description: active placebo for blinding; 0.5% polidocanol foam injection; 1.0% polidocanol foam injection; injection of vehicle comparator
Intervention MeSH terms: Polidocanol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 235.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: varicose veins

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 Endovenous
      Microfoam (PEM) 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 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