Trial · NCT01231373
Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
NCT01231373, Phase 3, Completed, Boston Scientific Corporation; results first posted 2014-04-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence. Trials, record NCT01231373. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01231373
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence
- NCT number
- NCT01231373
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 235 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Varicose Veins
- Interventions
- polidocanol injectable foam, 0.125%, polidocanol injectable foam, 0.5%, polidocanol injectable foam, 1.0%, Vehicle
- First posted
- 2010-11-01
- Last updated
- 2021-04-21
- Results first posted
- 2014-04-02
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) | 8 weeks | 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 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 VEINES QOL/Sym items that have been determined in earlier studies to be most important to patients. The daily VVSymQ score is the sum of the duration scores for these 5 symptoms (scores range from 0 to 25). 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 fo 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 | 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 (0-4, where 0=none and 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) | 8 weeks | Number of subjects with a baseline value (VVSymQ) and value at the 8 week visit. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) | 8 weeks | patients with a baseline and week 8 visit. | 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 | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
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 | -2.00 | Standard Error 0.474 | units on a scale | |
| Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score) | Polidocanol Injectable Foam, 0.125% | -5.34 | Standard Error 0.476 | units on a scale | |
| Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score) | Polidocanol Injectable Foam, 0.5% | -6.01 | Standard Error 0.454 | units on a scale | |
| Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score) | Polidocanol Injectable Foam, 1.0% | -5.06 | Standard Error 0.463 | units on a scale | |
| Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) | Vehicle | -0.07 | Standard Error 0.080 | units on a scale | |
| Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) | Polidocanol Injectable Foam, 0.125% | -0.74 | Standard Error 0.081 | units on a scale | |
| Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) | Polidocanol Injectable Foam, 0.5% | -0.89 | Standard Error 0.078 | units on a scale | |
| Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) | Polidocanol Injectable Foam, 1.0% | -0.83 | Standard Error 0.080 | units on a scale | |
| Change From Baseline at 8 Weeks Post-Treatment in IPR-V3 Score--Physician Photographic Review of Appearance | Vehicle | -0.32 | Standard Error 0.133 | units on a scale | |
| Change From Baseline at 8 Weeks Post-Treatment in IPR-V3 Score--Physician Photographic Review of Appearance | Polidocanol Injectable Foam, 0.125% | -1.55 | Standard Error 0.131 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vehicle | 59 | |
| Overall Study | STARTED | Polidocanol Injectable Foam, 0.125% | 58 | |
| Overall Study | STARTED | Polidocanol Injectable Foam, 0.5% | 60 | |
| Overall Study | STARTED | Polidocanol Injectable Foam, 1.0% | 58 | |
| Overall Study | Patients Receiving Blinded Treatment | Vehicle | 57 | |
| Overall Study | Patients Receiving Blinded Treatment | Polidocanol Injectable Foam, 0.125% | 57 | |
| Overall Study | Patients Receiving Blinded Treatment | Polidocanol Injectable Foam, 0.5% | 60 | |
| Overall Study | Patients Receiving Blinded Treatment | Polidocanol Injectable Foam, 1.0% | 58 | |
| Overall Study | COMPLETED | Vehicle | 56 | |
| Overall Study | COMPLETED | Polidocanol Injectable Foam, 0.125% | 57 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events36
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 | Infusion site thrombosis | General disorders | Vehicle | 0 | 59 | 0 |
| other | Infusion site thrombosis | General disorders | Polidocanol Injectable Foam, 0.125% | 6 | 58 | 6 |
| other | Infusion site thrombosis | General disorders | Polidocanol Injectable Foam, 0.5% | 7 | 60 | 7 |
| other | Infusion site thrombosis | General disorders | Polidocanol Injectable Foam, 1.0% | 16 | 58 | 16 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Vehicle | 7 | 59 | 7 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Polidocanol Injectable Foam, 0.125% | 9 | 58 | 9 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Polidocanol Injectable Foam, 0.5% | 4 | 60 | 4 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Polidocanol Injectable Foam, 1.0% | 10 | 58 | 10 |
| other | Thrombophlebitis superficial | Vascular disorders | Vehicle | 1 | 59 | 1 |
| other | Thrombophlebitis superficial | Vascular disorders | Polidocanol Injectable Foam, 0.125% | 4 | 58 | 4 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals12
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 | Polidocanol Injectable Foam, 0.5% | ||
| Total, all-cause mortality | Polidocanol Injectable Foam, 1.0% | ||
| Total, other adverse events | Vehicle | 11 | 59 |
| Total, other adverse events | Polidocanol Injectable Foam, 0.125% | 24 | 58 |
| Total, other adverse events | Polidocanol Injectable Foam, 0.5% | 27 | 60 |
| Total, other adverse events | Polidocanol Injectable Foam, 1.0% | 47 | 58 |
| Total, serious adverse events | Vehicle | 0 | 59 |
| Total, serious adverse events | Polidocanol Injectable Foam, 0.125% | 0 | 58 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26992303 | 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/NCT01231373
GET https://conductscience.org/api/trials/v1/NCT01231373/events?page=2