Trial · NCT01072877
Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
NCT01072877, Phase 3, Completed, Boston Scientific Corporation; results first posted 2014-05-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence. Trials, record NCT01072877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01072877
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
- NCT number
- NCT01072877
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 279 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Varicose Veins
- Interventions
- Polidocanol injectable foam (PEM), Placebo Vehicle
- First posted
- 2010-02-22
- Last updated
- 2021-04-21
- Results first posted
- 2014-05-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) | Week 8 | The 9 varicose vein symptoms were to be assessed and graded on a 6-point (i.e., 0-5) duration scale and an 11-point (i.e., 0-10) intensity scale, and the patient's level of activity for that day was to be assessed and graded on the 6-point (i.e., 0-5) duration scale. The 9 varicose vein symptoms assessed using the e-diary were derived from the first question of the modified Venous Insufficiency Epidemiologic and Economic Study-Quality of Life/Symptoms (VEINES-QOL/Sym) instrument. The VVSymQ is a subset of 5 VEINESQOL/ Sym items that have been determined in earlier studies to be most important to patients (heaviness, achiness, swelling, throbbing, and itching). The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25, with the lower end of the range being an indicator of less symptom intensity, and the higher end being an indicator of higher intensity). At Visit 2/baseline, Week 8, scores were calculated |
| Secondary | Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) | 8 weeks | The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this single-item paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from "Not at all noticeable" (a score of 0) to "Extremely noticeable" (a score of 4). |
| Secondary | Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance | 8 weeks post treatment | The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At baseline and Week 8, standardized digital photographs were taken of the medial view of the patient's target leg, from groin to ankle. An independent photography review panel, consisting of 3 trained, blinded clinicians evaluated the appearance of the patient's visible varicose veins using the IPR-V3 instrument's 5-point scale (where 0=none to 4=very severe visible varicose veins). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) | Week 8 | units on a scale | MEAN | |
| SECONDARY | Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) | 8 weeks | units on a scale | MEAN | |
| SECONDARY | Change From Baseline at 8 Weeks Post Treatment in IPR-V3 Score- Physician Photographic Review of Appearance | 8 weeks post treatment | Population consists of all patients who had a baseline and on-treatment assessment. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) | Vehicle | 2.13 | Standard Error 0.452 | units on a scale | |
| Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) | Polidocanol Injectable Foam 0.125% | 4.63 | Standard Error 0.447 | units on a scale | |
| Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) | Polidocanol Injectable Foam 0.5% | 5.68 | Standard Error 0.483 | units on a scale | |
| Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) | Polidocanol Injectable Foam 1.0% | 4.87 | Standard Error 0.477 | units on a scale | |
| Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score) | Polidocanol Injectable Foam 2.0% | 5.78 | Standard Error 0.425 | units on a scale | |
| Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) | Vehicle | -0.15 | Standard Error 0.143 | units on a scale | |
| Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) | Polidocanol Injectable Foam 0.125% | -0.93 | Standard Error 0.142 | units on a scale | |
| Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) | Polidocanol Injectable Foam 0.5% | -1.40 | Standard Error 0.152 | units on a scale | |
| Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) | Polidocanol Injectable Foam 1.0% | -1.60 | Standard Error 0.151 | units on a scale | |
| Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) | Polidocanol Injectable Foam 2.0% | -1.75 | Standard Error 0.135 | units on a scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vehicle | 56 | |
| Overall Study | STARTED | Polidocanol Endovenous Microfoam 0.125% | 57 | |
| Overall Study | STARTED | Polidocanol Endovenous Microfoam 0.5% | 51 | |
| Overall Study | STARTED | Polidocanol Endovenous Microfoam 1.0% | 52 | |
| Overall Study | STARTED | Polidocanol Endovenous Microfoam 2.0% | 63 | |
| Overall Study | COMPLETED | Vehicle | 55 | |
| Overall Study | COMPLETED | Polidocanol Endovenous Microfoam 0.125% | 56 | |
| Overall Study | COMPLETED | Polidocanol Endovenous Microfoam 0.5% | 51 | |
| Overall Study | COMPLETED | Polidocanol Endovenous Microfoam 1.0% | 50 | |
| Overall Study | COMPLETED | Polidocanol Endovenous Microfoam 2.0% | 63 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Vehicle | 5 | 56 | 5 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Polidocanol Injectable Foam 0.125% | 11 | 57 | 11 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Polidcanol Injectable Foam 0.5% | 10 | 51 | 10 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Polidocanol Injectable Foam 1.0% | 10 | 52 | 10 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Polidocanol Endovenous Microfoam 2.0% | 6 | 63 | 6 |
| other | Thrombophlebitis superficial | Vascular disorders | Vehicle | 1 | 56 | 1 |
| other | Thrombophlebitis superficial | Vascular disorders | Polidocanol Injectable Foam 0.125% | 7 | 57 | 7 |
| other | Thrombophlebitis superficial | Vascular disorders | Polidcanol Injectable Foam 0.5% | 5 | 51 | 5 |
| other | Thrombophlebitis superficial | Vascular disorders | Polidocanol Injectable Foam 1.0% | 4 | 52 | 4 |
| other | Thrombophlebitis superficial | Vascular disorders | Polidocanol Endovenous Microfoam 2.0% | 8 | 63 | 8 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vehicle | ||
| Total, all-cause mortality | Polidocanol Injectable Foam 0.125% | ||
| Total, all-cause mortality | Polidcanol Injectable Foam 0.5% | ||
| Total, all-cause mortality | Polidocanol Injectable Foam 1.0% | ||
| Total, all-cause mortality | Polidocanol Endovenous Microfoam 2.0% | ||
| Total, other adverse events | Vehicle | 20 | 56 |
| Total, other adverse events | Polidocanol Injectable Foam 0.125% | 38 | 57 |
| Total, other adverse events | Polidcanol Injectable Foam 0.5% | 46 | 51 |
| Total, other adverse events | Polidocanol Injectable Foam 1.0% | 41 | 52 |
| Total, other adverse events | Polidocanol Endovenous Microfoam 2.0% | 50 | 63 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26384639 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01072877
GET https://conductscience.org/api/trials/v1/NCT01072877/events?page=2