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

NCT ID: NCT00758420

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-08-31

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.

Conditions

Varicose Veins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Varisolve (polidocanol endovenous mircofoam)

Group Type: ACTIVE_COMPARATOR

Varisolve (Polidocanol Endovenous Microfoam)

Intervention Type: DRUG

1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2)

2

Agitated saline

Group Type: PLACEBO_COMPARATOR

Agitated Saline

Intervention Type: DRUG

10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session

Interventions

Varisolve (Polidocanol Endovenous Microfoam)

1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2)

Intervention Type: DRUG

Agitated Saline

10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janet Rush, MD

Role: STUDY_CHAIR

BTG International Inc.

Locations

Scottsdale, Arizona, United States

New York, New York, United States

Charlotte, North Carolina, United States

Winston-Salem, North Carolina, United States

Bellevue, Washington, United States

Countries

United States

References

Gibson K, Kabnick L; Varithena(R) 013 Investigator Group. A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of Varithena(R) (polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence. Phlebology. 2017 Apr;32(3):185-193. doi: 10.1177/0268355516635386. Epub 2016 Jul 9.

Reference Type: DERIVED

PMID: 27013511 (View on PubMed)

Related Links

http://www.veinstudy.com

Study Website

Other Identifiers

VAP.VV013

Identifier Type: -

Identifier Source: org_study_id