CompletedNCT00758420PilotUpdated Apr 21, 2021Results posted

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

A Phase 2/3 interventional study of Varisolve (Polidocanol Endovenous Microfoam) and Agitated Saline in Varicose Veins, sponsored by Boston Scientific Corporation. Completed at 5 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-04-21.

Sponsored by Boston Scientific Corporation · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 77
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the 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 studied

Varicose Veins

Browse trials for

Varicose Veins 253

Keywords

Varicose Veins

In context

Varicose Veins

253 studies on the registry are indexed under Varicose Veins; 35 are open to participants now.

This study's enrollment of 77 is below the median of 104 across 162 interventional studies indexed under Varicose Veins.

Browse Varicose Veins studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 77 participants (actual)

Study arms

Active comparator
1
Varisolve (polidocanol endovenous mircofoam)
Drug: Varisolve (Polidocanol Endovenous Microfoam)
Placebo comparator
2
Agitated saline
Drug: Agitated Saline

Interventions

DrugVarisolve (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)
DrugAgitated Saline
10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session

What researchers measure

Primary outcomes

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

Results

Posted Mar 24, 2014

Participant flow

Participant flow — Overall Study
Milestone	Active Treatment	Placebo
Started	39	38
Completed	39	38
Not completed	0	0

Outcome measures

PrimaryThe 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
Reported as:: Least squares mean · units on a scale

The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks
units on a scale	Placebo	Polidocanol Injectable Foam, 1.0%
The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks	16.7 ± 3.18	30.7 ± 3.04

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	—	1/38 (2.6%)	19/38 (50%)
Polidocanol Injectable Foam, 1.0%	—	1/39 (2.6%)	36/39 (92.3%)

Most frequent serious events

Most frequent serious events
Event	Placebo	Polidocanol Injectable Foam, 1.0%
Transient ischemic attackNervous system disorders	1/38	0/39
Sick sinus syndromeCardiac disorders	0/38	1/39

Most frequent other events

Showing 10 of 21

Most frequent other events
Event	Placebo	Polidocanol Injectable Foam, 1.0%
contusionInjury, poisoning and procedural complications	2/38	10/39
limb discomfortMusculoskeletal and connective tissue disorders	1/38	10/39
pain in extremityMusculoskeletal and connective tissue disorders	1/38	6/39
pruritisSkin and subcutaneous tissue disorders	5/38	3/39
deep vein thrombosisVascular disorders	0/38	5/39
incision site hematomaInjury, poisoning and procedural complications	3/38	4/39
myalgiaMusculoskeletal and connective tissue disorders	0/38	4/39
headacheNervous system disorders	0/38	4/39
thrombectomySurgical and medical procedures	0/38	4/39
skin irritationSkin and subcutaneous tissue disorders	3/38	2/39

Baseline characteristics

Treated patients with a week 8 study assessment.

Age, Continuous
Age, Continuous(years)	Placebo	Polidocanol Injectable Foam, 1.0%	Total
Mean	44.9 ± 10.71	45.3 ± 10.75	45.1 ± 10.66

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Polidocanol Injectable Foam, 1.0%	Total
Female	32	30	62
Male	6	9	15

Baseline VCSS
Baseline VCSS(units on a scale)	Placebo	Polidocanol Injectable Foam, 1.0%	Total
Mean	6.0 ± 1.95	6.6 ± 2.05	6.3 ± 2.01

CEAP Clinical classification
CEAP Clinical classification(participants)	Placebo	Polidocanol Injectable Foam, 1.0%	Total
C3 - Edema	34	35	69
C4 - Skin Change Without Ulceration	4	2	6
C5 - Skin Change With Healed Ulceration	0	2	2

VVSymQ Score
VVSymQ Score(units on a scale)	Placebo	Polidocanol Injectable Foam, 1.0%	Total
Mean	57.5 ± 27.97	52.6 ± 29.37	55.0 ± 28.60

VEINES-Sym Score
VEINES-Sym Score(units on a scale)	Placebo	Polidocanol Injectable Foam, 1.0%	Total
Mean	61.9 ± 26.05	59.3 ± 26.11	60.6 ± 25.94

Study locations

5 sites

Scottsdale, Arizona 85255, United States
New York, New York 10016, United States
Charlotte, North Carolina 28207, United States
Winston-Salem, North Carolina 27157, United States
Bellevue, Washington 98004, United States

References and documents

Publications

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. PubMed 27013511 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00758420
Lead sponsor: Boston Scientific Corporation
Responsible party: Sponsor
First posted: Sep 25, 2008
Start date: Oct 2008
Primary completion: Jul 2009
Completion: Aug 2009
Results posted: Mar 24, 2014
Last update: Apr 21, 2021

Study contacts

Janet Rush, MD

study chair · BTG International Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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