Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence (Pilot)
Primary Purpose
Varicose Veins
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Varisolve (Polidocanol Endovenous Microfoam)
Agitated Saline
Sponsored by
About this trial
This is an interventional treatment trial for Varicose Veins focused on measuring Varicose Veins
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Varisolve (polidocanol endovenous mircofoam)
Agitated saline
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00758420
First Posted
September 22, 2008
Last Updated
April 19, 2021
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00758420
Brief Title
Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence
Acronym
Pilot
Official Title
A Randomized, Single Blind, Placebo Controlled, Multicenter Study to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for the Treatment of Symptomatic, Visible Varicose Veins With Saphenofemoral Junction (SFJ) Incompetence.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins
Keywords
Varicose Veins
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Varisolve (polidocanol endovenous mircofoam)
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Agitated saline
Intervention Type
Drug
Intervention Name(s)
Varisolve (Polidocanol Endovenous Microfoam)
Intervention Description
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
Intervention Name(s)
Agitated Saline
Intervention Description
10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session
Primary Outcome Measure Information:
Title
The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Rush, MD
Organizational Affiliation
BTG International Inc.
Official's Role
Study Chair
Facility Information:
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27013511
Citation
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.
Results Reference
derived
Links:
URL
http://www.veinstudy.com
Description
Study Website
Learn more about this trial
Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence
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