Trial Outcomes & Findings for Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (NCT NCT01072877)

Last Updated: 2021-04-21

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

279 participants

Primary outcome timeframe

Week 8

Results posted on

2021-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Vehicle Injection of vehicle comparator Placebo Vehicle: Placebo vehicle	Polidocanol Endovenous Microfoam 0.125% Polidocanol endovenous microfoam 0.125% Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam	Polidocanol Endovenous Microfoam 0.5% Polidocanol endovenous microfoam 0.5% Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam	Polidocanol Endovenous Microfoam 1.0% Polidocanol endovenous microfoam 1.0% Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam	Polidocanol Endovenous Microfoam 2.0% Polidocanol endovenous microfoam 2.0% Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam
Overall Study STARTED	56	57	51	52	63
Overall Study COMPLETED	55	56	51	50	63
Overall Study NOT COMPLETED	1	1	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Vehicle Injection of vehicle comparator Placebo Vehicle: Placebo vehicle	Polidocanol Endovenous Microfoam 0.125% Polidocanol endovenous microfoam 0.125% Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam	Polidocanol Endovenous Microfoam 0.5% Polidocanol endovenous microfoam 0.5% Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam	Polidocanol Endovenous Microfoam 1.0% Polidocanol endovenous microfoam 1.0% Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam	Polidocanol Endovenous Microfoam 2.0% Polidocanol endovenous microfoam 2.0% Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam
Overall Study Lost to Follow-up	1	1	0	2	0

Baseline Characteristics

Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vehicle n=56 Participants Injection of vehicle comparator Placebo Vehicle: Placebo vehicle	Polidocanol Injectable Foam 0.125% n=57 Participants Polidocanol injectable foam 0.125%	Polidocanol Injectable Foam 0.5% n=51 Participants Polidocanol injectable foam 0.5%	Polidocanol Injectable Foam 1.0% n=52 Participants Polidocanol injectable foam 1.0%	Polidocanol Injectable Foam 2.0% n=63 Participants Polidocanol injectable foam2.0%	Total n=279 Participants Total of all reporting groups
Age, Continuous	46.0 years STANDARD_DEVIATION 11.31 • n=93 Participants	51.6 years STANDARD_DEVIATION 9.60 • n=4 Participants	48.2 years STANDARD_DEVIATION 11.78 • n=27 Participants	48.8 years STANDARD_DEVIATION 8.78 • n=483 Participants	49.7 years STANDARD_DEVIATION 10.49 • n=36 Participants	48.9 years STANDARD_DEVIATION 10.54 • n=10 Participants
Sex: Female, Male Female	44 Participants n=93 Participants	42 Participants n=4 Participants	37 Participants n=27 Participants	38 Participants n=483 Participants	47 Participants n=36 Participants	208 Participants n=10 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	15 Participants n=4 Participants	14 Participants n=27 Participants	14 Participants n=483 Participants	16 Participants n=36 Participants	71 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	3 Participants n=10 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	2 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	4 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	7 Participants n=10 Participants
Race (NIH/OMB) White	52 Participants n=93 Participants	51 Participants n=4 Participants	46 Participants n=27 Participants	50 Participants n=483 Participants	61 Participants n=36 Participants	260 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	6 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
BMI	27.7 kg/m^2 STANDARD_DEVIATION 5.95 • n=93 Participants	28.8 kg/m^2 STANDARD_DEVIATION 5.77 • n=4 Participants	27.4 kg/m^2 STANDARD_DEVIATION 5.75 • n=27 Participants	28.6 kg/m^2 STANDARD_DEVIATION 5.41 • n=483 Participants	28.3 kg/m^2 STANDARD_DEVIATION 5.40 • n=36 Participants	28.2 kg/m^2 STANDARD_DEVIATION 5.64 • n=10 Participants

PRIMARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Vehicle n=55 Participants Injection of vehicle Placebo Vehicle: Placebo vehicle	Polidocanol Injectable Foam 0.125% n=56 Participants Polidocanol injectable foam at a 0.125% concentration	Polidocanol Injectable Foam 0.5% n=51 Participants polidocanol injectable foam at a 0.5% concentration	Polidocanol Injectable Foam 1.0% n=50 Participants Polidocanol injectable foam at 1.0% concentration	Polidocanol Injectable Foam 2.0% n=63 Participants Polidocanol injectable foam at a 2.0% concentration
Change in Patient-reported Symptoms of Varicose Veins (VVSymQ Score)	2.13 units on a scale Standard Error 0.452	4.63 units on a scale Standard Error 0.447	5.68 units on a scale Standard Error 0.483	4.87 units on a scale Standard Error 0.477	5.78 units on a scale Standard Error 0.425

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Vehicle n=55 Participants Injection of vehicle Placebo Vehicle: Placebo vehicle	Polidocanol Injectable Foam 0.125% n=56 Participants Polidocanol injectable foam at a 0.125% concentration	Polidocanol Injectable Foam 0.5% n=51 Participants polidocanol injectable foam at a 0.5% concentration	Polidocanol Injectable Foam 1.0% n=50 Participants Polidocanol injectable foam at 1.0% concentration	Polidocanol Injectable Foam 2.0% n=63 Participants Polidocanol injectable foam at a 2.0% concentration
Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)	-0.15 units on a scale Standard Error 0.143	-0.93 units on a scale Standard Error 0.142	-1.40 units on a scale Standard Error 0.152	-1.60 units on a scale Standard Error 0.151	-1.75 units on a scale Standard Error 0.135

SECONDARY outcome

Timeframe: 8 weeks post treatment

Population: Population consists of all patients who had a baseline and on-treatment assessment.

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).