Varicose VeinsPhase 2/3PilotNCT00758420
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 study testing Varisolve (Polidocanol Endovenous Microfoam) and Agitated Saline in people with Varicose Veins, run by Boston Scientific Corporation at 5 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Varisolve (Polidocanol Endovenous Microfoam) and Agitated Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2008to Aug 2009
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Bellevue, Washington, 98004
Study site
Charlotte, North Carolina, 28207
Study site
New York, New York, 10016
Study site
Scottsdale, Arizona, 85255
Study site
Winston-Salem, North Carolina, 27157
About this study
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.
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
- Varicose Veins
- Being tested
- Varisolve (Polidocanol Endovenous Microfoam), Agitated Saline
- Keywords
- Varicose Veins
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varisolve (Polidocanol Endovenous Microfoam)Drug
1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2)
Agitated SalineDrug
10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Varisolve (polidocanol endovenous mircofoam) Receives: Drug: Varisolve (Polidocanol Endovenous Microfoam) |
| 2 | Placebo comparator | Agitated saline Receives: Drug: Agitated Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janet Rush, MD, Study chair, BTG International Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758420
- Sponsor's protocol ID
- VAP.VV013
- Acronym
- Pilot
- Status last verified
- Apr 2021
- First submitted
- 22 Sep 2008
- Last updated
- 21 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00758420
- Acronym / sponsor ID
- Pilot / VAP.VV013
- Conditions
- Varicose Veins
- Keywords
- Varicose Veins
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 24 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Varisolve (Polidocanol Endovenous Microfoam)Varisolve (polidocanol endovenous mircofoam) |
| 2 | Placebo comparator | Drug: Agitated SalineAgitated saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | 1 |
| Agitated Saline10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session | Drug | 2 |
Primary outcome
The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27013511Gibson 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.
- Study WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Rush, MD study chair
BTG International Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Varisolve (Polidocanol Endovenous Microfoam) and Agitated Saline in people with Varicose Veins, run by Boston Scientific Corporation at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00758420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.