Trial Outcomes & Findings for An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins (NCT NCT00928421)
NCT ID: NCT00928421
Last Updated: 2021-05-13
Results Overview
Responders; elimination of reflux through the saphenofemoral junction and/or coplete occlusion of the great saphenous vein at 8 weeks, as measured by duplex ultrasound.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
8 weeks
Results posted on
2021-05-13
Participant Flow
Participant milestones
| Measure |
Polidocanol Injectable Foam 0.125%
polidocanol injectable foam 0.125%, single dose
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
Treated With Study Drug
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-label, Single-dose Pilot Study to Evaluate Varisolve® (Polidocanol Endovenous Microfoam (PEM)) 0.125% [0.2%] for Varicose Veins
Baseline characteristics by cohort
| Measure |
Polidocanol Injectable Foam 0.125%
n=16 Participants
polidocanol injectable foam 0.125%, single dose
|
|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 10.44 • n=93 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Body Mass Index
|
29.0 kg/m^2
STANDARD_DEVIATION 6.73 • n=93 Participants
|
PRIMARY outcome
Timeframe: 8 weeksResponders; elimination of reflux through the saphenofemoral junction and/or coplete occlusion of the great saphenous vein at 8 weeks, as measured by duplex ultrasound.
Outcome measures
| Measure |
Polidocanol Injectable Foam 0.125%
n=16 Participants
polidocanol injectable foam 0.125%, single dose
|
|---|---|
|
Responders to Treatment, Assessed by Duplex Ultrasound
|
9 participants
|
Adverse Events
Polidocanol Injectable Foam 0.125%
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Polidocanol Injectable Foam 0.125%
n=16 participants at risk
polidocanol injectable foam 0.125%, single dose
|
|---|---|
|
General disorders
extravasation
|
6.2%
1/16 • Number of events 1
|
|
General disorders
local swelling
|
12.5%
2/16 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
limb discomfort
|
50.0%
8/16 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
12.5%
2/16 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place