Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence

Phase 2

Completed

Interventions: Drug: Varisolve (Polidocanol Endovenous Microfoam)
Drug: Agitated Saline

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Males and Females 18-65 years old
VEINES Sym Score less than 75 points
Varicose Vein clinical classification CEAP 2, 3, 4, or 5
Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
Superficial venous disease manifested by both symptoms and visible varicosities
Ability to comprehend and sign an informed consent document and completed study questionnaires in English

Exclusion Criteria

Incompetence of the SSV which substantially contributes to the filling of visible varicose veins
Current or previous Deep Vein Thrombosis
Leg obesity
Peripheral arterial disease in the leg to be treated
Reduced mobility
Planned prolonged travel with limited mobility with in 4 weeks of treatment
History of pulmonary embolism or stroke
Major surgery, prolonged hospitalization or pregnancy within 3 months
Current anticoagulation therapy (within 7 days of enrollment)
Participation in a clinical study involving a investigational product within 3 months
Major co-existing disease or clinically significant laboratory abnormalities
Known allergic response to polidocanol or heparin or severe and/or multiple allergic reactions
Women of childbearing potential not using effective contraception one month prior to enrollment and/or unwilling to continue while on study
Pregnant or lactating women
Current alcohol or drug abuse

Arm && Interventions

Group	Intervention	Description
1	Varisolve (Polidocanol Endovenous Microfoam)	Varisolve (polidocanol endovenous mircofoam)
2	Agitated Saline	Agitated saline

Primary Outcome Measures

Name	Time	Method
The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks	Baseline to 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.

Secondary Outcome Measures