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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
77
1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2)
10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Charlotte, North Carolina, United States
Unnamed facility
Winston-Salem, North Carolina, United States
Unnamed facility
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.
Time frame: Baseline to 8 weeks
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Bellevue, Washington, United States