Status:
COMPLETED
Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Varicose Veins
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00758420
Start Date
October 1 2008
End Date
August 1 2009
Last Update
April 21 2021
Active Locations (5)
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1
Scottsdale, Arizona, United States, 85255
2
New York, New York, United States, 10016
3
Charlotte, North Carolina, United States, 28207
4
Winston-Salem, North Carolina, United States, 27157