Trial Outcomes & Findings for Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (NCT NCT01231373)

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 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

235 participants

Primary outcome timeframe

8 weeks

Results posted on

2021-04-21

Participant Flow

Three (3) patients were randomized but never treated.

Participant milestones

Participant milestones
Measure	Vehicle Vehicle: Injection of vehicle comparator	Polidocanol Injectable Foam, 0.125% active placebo for blinding of therapeutic polidocanol dose	Polidocanol Injectable Foam, 0.5% lower experimental polidocanol dose	Polidocanol Injectable Foam, 1.0% 1.0% polidocanol foam injection
Overall Study STARTED	59	58	60	58
Overall Study Patients Receiving Blinded Treatment	57	57	60	58
Overall Study COMPLETED	56	57	60	57
Overall Study NOT COMPLETED	3	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Vehicle Vehicle: Injection of vehicle comparator	Polidocanol Injectable Foam, 0.125% active placebo for blinding of therapeutic polidocanol dose	Polidocanol Injectable Foam, 1.0% 1.0% polidocanol foam injection
Overall Study Withdrew consent prior to randomization	2	1	0
Overall Study Lost to Follow-up	0	0	1
Overall Study Withdrew Consent	1	0	0

Baseline Characteristics

Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vehicle n=57 Participants Vehicle: Injection of vehicle comparator	Polidocanol Injectable Foam, 0.125% n=57 Participants polidocanol injectable foam active placebo	Polidocanol Injectable Foam, 0.5% n=60 Participants polidocanol injectable foam lower experimental dose	Polidocanol Injectable Foam, 1.0% n=58 Participants polidocanol injectable foam therapeutic dose	Total n=232 Participants Total of all reporting groups
Age, Continuous	49.8 years STANDARD_DEVIATION 10.44 • n=5 Participants	52.8 years STANDARD_DEVIATION 10.06 • n=7 Participants	50.4 years STANDARD_DEVIATION 9.89 • n=5 Participants	50.4 years STANDARD_DEVIATION 11.42 • n=4 Participants	50.8 years STANDARD_DEVIATION 10.47 • n=21 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	43 Participants n=7 Participants	40 Participants n=5 Participants	44 Participants n=4 Participants	169 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants	14 Participants n=4 Participants	63 Participants n=21 Participants
Race/Ethnicity, Customized White	54 participants n=5 Participants	53 participants n=7 Participants	55 participants n=5 Participants	53 participants n=4 Participants	215 participants n=21 Participants
Race/Ethnicity, Customized Black	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants	0 participants n=4 Participants	6 participants n=21 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants
Race/Ethnicity, Customized American Indian/Eskimo	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	3 participants n=4 Participants	8 participants n=21 Participants
Weight	83.0 kilograms STANDARD_DEVIATION 20.22 • n=5 Participants	85.3 kilograms STANDARD_DEVIATION 16.41 • n=7 Participants	88.8 kilograms STANDARD_DEVIATION 22.66 • n=5 Participants	81.4 kilograms STANDARD_DEVIATION 20.22 • n=4 Participants	84.8 kilograms STANDARD_DEVIATION 20.11 • n=21 Participants
Height	169.7 centimeters STANDARD_DEVIATION 9.45 • n=5 Participants	168.6 centimeters STANDARD_DEVIATION 9.38 • n=7 Participants	169.6 centimeters STANDARD_DEVIATION 10.47 • n=5 Participants	169.1 centimeters STANDARD_DEVIATION 9.27 • n=4 Participants	169.3 centimeters STANDARD_DEVIATION 9.61 • n=21 Participants
Calculated BMI	28.8 kg/m^2 STANDARD_DEVIATION 5.76 • n=5 Participants	30.1 kg/m^2 STANDARD_DEVIATION 19.48 • n=7 Participants	30.7 kg/m^2 STANDARD_DEVIATION 6.28 • n=5 Participants	28.4 kg/m^2 STANDARD_DEVIATION 6.45 • n=4 Participants	29.5 kg/m^2 STANDARD_DEVIATION 6.03 • n=21 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Number of subjects with a baseline value (VVSymQ) and value at the 8 week visit.

Outcome measures

Outcome measures
Measure	Vehicle n=54 Participants Vehicle: Injection of vehicle comparator	Polidocanol Injectable Foam, 0.125% n=54 Participants polidocanol injectable foam, 0.125%: active placebo for blinding	Polidocanol Injectable Foam, 0.5% n=60 Participants experimental dose polidocanol injectable foam, 0.5%	Polidocanol Injectable Foam, 1.0% n=57 Participants polidocanol injectable foam, 1.0%: Injection of mid-dose PEM
Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score)	-2.00 units on a scale Standard Error 0.474	-5.34 units on a scale Standard Error 0.476	-6.01 units on a scale Standard Error 0.454	-5.06 units on a scale Standard Error 0.463

SECONDARY outcome

Timeframe: 8 weeks

Population: patients with a baseline and week 8 visit.

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).

Outcome measures

Outcome measures
Measure	Vehicle n=56 Participants Vehicle: Injection of vehicle comparator	Polidocanol Injectable Foam, 0.125% n=56 Participants polidocanol injectable foam, 0.125%: active placebo for blinding	Polidocanol Injectable Foam, 0.5% n=60 Participants experimental dose polidocanol injectable foam, 0.5%	Polidocanol Injectable Foam, 1.0% n=57 Participants polidocanol injectable foam, 1.0%: Injection of mid-dose PEM
Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3)	-0.07 units on a scale Standard Error 0.080	-0.74 units on a scale Standard Error 0.081	-0.89 units on a scale Standard Error 0.078	-0.83 units on a scale Standard Error 0.080

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Vehicle n=56 Participants Vehicle: Injection of vehicle comparator	Polidocanol Injectable Foam, 0.125% n=57 Participants polidocanol injectable foam, 0.125%: active placebo for blinding	Polidocanol Injectable Foam, 0.5% n=60 Participants experimental dose polidocanol injectable foam, 0.5%	Polidocanol Injectable Foam, 1.0% n=57 Participants polidocanol injectable foam, 1.0%: Injection of mid-dose PEM
Change From Baseline at 8 Weeks Post-Treatment in IPR-V3 Score--Physician Photographic Review of Appearance	-0.32 units on a scale Standard Error 0.133	-1.55 units on a scale Standard Error 0.131	-1.86 units on a scale Standard Error 0.129	-1.79 units on a scale Standard Error 0.130

Adverse Events

Vehicle

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Polidocanol Injectable Foam, 0.125%

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Polidocanol Injectable Foam, 0.5%

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Polidocanol Injectable Foam, 1.0%

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vehicle n=59 participants at risk Vehicle: Injection of vehicle comparator	Polidocanol Injectable Foam, 0.125% n=58 participants at risk polidocanol injectable foam, 0.125% active placebo	Polidocanol Injectable Foam, 0.5% n=60 participants at risk polidocanol injectable foam, 0.5% lower experimental dose	Polidocanol Injectable Foam, 1.0% n=58 participants at risk polidocanol injectable foam target therapeutic dose
General disorders Infusion site thrombosis	0.00% 0/59 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	10.3% 6/58 • Number of events 6 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	11.7% 7/60 • Number of events 7 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	27.6% 16/58 • Number of events 16 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)
Musculoskeletal and connective tissue disorders Pain in extremity	11.9% 7/59 • Number of events 7 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	15.5% 9/58 • Number of events 9 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	6.7% 4/60 • Number of events 4 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	17.2% 10/58 • Number of events 10 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)
Vascular disorders Thrombophlebitis superficial	1.7% 1/59 • Number of events 1 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	6.9% 4/58 • Number of events 4 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	13.3% 8/60 • Number of events 8 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	3.4% 2/58 • Number of events 2 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)
Vascular disorders Venous thrombosis limb	0.00% 0/59 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	3.4% 2/58 • Number of events 2 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	3.3% 2/60 • Number of events 2 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	6.9% 4/58 • Number of events 4 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)
Vascular disorders Hematoma	1.7% 1/59 • Number of events 1 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	3.4% 2/58 • Number of events 2 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	5.0% 3/60 • Number of events 3 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	5.2% 3/58 • Number of events 3 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)
Musculoskeletal and connective tissue disorders Limb discomfort	3.4% 2/59 • Number of events 2 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	1.7% 1/58 • Number of events 1 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	3.3% 2/60 • Number of events 2 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	5.2% 3/58 • Number of events 3 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)
Vascular disorders Deep vein thrombosis	0.00% 0/59 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	0.00% 0/58 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	0.00% 0/60 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	8.6% 5/58 • Number of events 5 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)
General disorders Tenderness	0.00% 0/59 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	0.00% 0/58 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	1.7% 1/60 • Number of events 1 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	6.9% 4/58 • Number of events 4 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)
Musculoskeletal and connective tissue disorders Back pain	5.1% 3/59 • Number of events 3 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	0.00% 0/58 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	0.00% 0/60 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)	1.7% 1/58 • Number of events 1 • Adverse events that occurred after patient provided informed consent through Visit 5/Week 8 (or Visit 8 for patients receiving open-label PEM 1.0%)

Additional Information

David Wright MBBS

BTG International Inc.

Phone: 610-278-1660

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60