Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)
Condition: Varicose Veins
MeSH terms: Varicose Veins
Intervention: Polidocanol Endovenous Microfoam (PEM)
Intervention description: Pharmacokinetic comparison of different doses of drug
Intervention MeSH terms: Polidocanol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Varicose Veins; SFJ Reflux

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 pharmacokinetic profile
      of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM), an
      investigational treatment for varicose veins.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female; age 18 to 75 years

          -  Superficial venous disease where SFJ incompetence is the predominant source of reflux
             (reflux > 0.5 seconds on duplex ultrasonography) associated with incompetence of the
             great saphenous vein (GSV) or other major accessory vein

          -  Expected need for microfoam of 10 mL to fill the incompetent GSV and tributaries
             (minimum trunk vein diameter of 6mm)

          -  Clinically normal renal and hepatic function on serum chemistry

          -  Ability to comprehend and sign an informed consent document in English

        Exclusion Criteria:

          -  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.)

          -  Clinically significant abnormal ECG or clinical condition which may affect
             interpretation of ECG, for example, history of Long QT Syndrome, Brugada Syndrome,
             electronic cardiac pacemaker, chronic atrial fibrillation, recent myocardial
             infarction or congestive heart failure.

          -  Patients taking QT prolonging medications

          -  Any of the following findings on screening ECG:

          -  QRS > 110 ms

          -  HR < 45 bpm

          -  HR > 100 bpm

          -  QTcF > 470 ms

          -  PR > 220 ms

          -  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 venous reflux unless clinically insignificant in comparison to superficial reflux

          -  Peripheral arterial disease precluding the wearing of post-procedure compression
             bandaging and stockings

          -  Reduced mobility (unable to walk unaided for 5 minutes per waking hour)

          -  History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of
             prior DVT on duplex ultrasound

          -  Major surgery, prolonged hospitalization or pregnancy within 3 months of screening

          -  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 for at least one
             month prior to study enrollment (i.e., treatment) and/or unwilling to continue birth
             control until Visit 4

          -  Participation in a clinical study involving an investigational pharmaceutical product
             or device within the 3 months prior to screening

          -  Previous treatment with Polidocanol Endovenous Microfoam (PEM) in a previous PEM study