Trial Outcomes & Findings for Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence (NCT NCT00758420)
NCT ID: NCT00758420
Last Updated: 2021-04-21
Results Overview
The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = \[(Raw Score) - 5\] \* 4.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
77 participants
Primary outcome timeframe
Baseline to 8 weeks
Results posted on
2021-04-21
Participant Flow
Participant milestones
| Measure |
Active Treatment
polidocanol injectiable foam 1%, up to 15 mL, one treatment session
|
Placebo
Agitated saline
Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
38
|
|
Overall Study
COMPLETED
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized, Single Blind, Placebo Controlled, to Evaluate Efficacy and Safety of Polidocanol Injectable Foam for Treatment of Symptomatic, Visible Varicose Veins With SFJ Incompetence
Baseline characteristics by cohort
| Measure |
Placebo
n=38 Participants
Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session
|
Polidocanol Injectable Foam, 1.0%
n=39 Participants
Polidocanol injectable foam 1%, up to 15 mL, one treatment session
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 10.71 • n=5 Participants
|
45.3 years
STANDARD_DEVIATION 10.75 • n=7 Participants
|
45.1 years
STANDARD_DEVIATION 10.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Baseline VCSS
|
6.0 units on a scale
STANDARD_DEVIATION 1.95 • n=5 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 2.05 • n=7 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 2.01 • n=5 Participants
|
|
CEAP Clinical classification
C3 - Edema
|
34 participants
n=5 Participants
|
35 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
CEAP Clinical classification
C4 - Skin Change Without Ulceration
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
CEAP Clinical classification
C5 - Skin Change With Healed Ulceration
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
VVSymQ Score
|
57.5 units on a scale
STANDARD_DEVIATION 27.97 • n=5 Participants
|
52.6 units on a scale
STANDARD_DEVIATION 29.37 • n=7 Participants
|
55.0 units on a scale
STANDARD_DEVIATION 28.60 • n=5 Participants
|
|
VEINES-Sym Score
|
61.9 units on a scale
STANDARD_DEVIATION 26.05 • n=5 Participants
|
59.3 units on a scale
STANDARD_DEVIATION 26.11 • n=7 Participants
|
60.6 units on a scale
STANDARD_DEVIATION 25.94 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksThe VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = \[(Raw Score) - 5\] \* 4.
Outcome measures
| Measure |
Placebo
n=38 Participants
agitated saline
|
Polidocanol Injectable Foam, 1.0%
n=39 Participants
polidocanol injectable foam 1%, up to 15 mL, one treatment session
|
|---|---|---|
|
The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks
|
16.7 units on a scale
Standard Error 3.18
|
30.7 units on a scale
Standard Error 3.04
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Polidocanol Injectable Foam, 1.0%
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=38 participants at risk
agitated saline
|
Polidocanol Injectable Foam, 1.0%
n=39 participants at risk
polidocanol injectable foam 1%, up to 15 mL, one treatment session
|
|---|---|---|
|
Nervous system disorders
Transient ischemic attack
|
2.6%
1/38 • Number of events 1
|
0.00%
0/39
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/38
|
2.6%
1/39 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=38 participants at risk
agitated saline
|
Polidocanol Injectable Foam, 1.0%
n=39 participants at risk
polidocanol injectable foam 1%, up to 15 mL, one treatment session
|
|---|---|---|
|
General disorders
chest discomfort
|
0.00%
0/38
|
5.1%
2/39 • Number of events 2
|
|
General disorders
edema
|
0.00%
0/38
|
5.1%
2/39 • Number of events 2
|
|
Infections and infestations
nasopharyngitis
|
2.6%
1/38 • Number of events 1
|
5.1%
2/39 • Number of events 2
|
|
Injury, poisoning and procedural complications
contusion
|
5.3%
2/38 • Number of events 2
|
25.6%
10/39 • Number of events 10
|
|
Injury, poisoning and procedural complications
incision site complication
|
2.6%
1/38 • Number of events 1
|
7.7%
3/39 • Number of events 3
|
|
Injury, poisoning and procedural complications
incision site hematoma
|
7.9%
3/38 • Number of events 3
|
10.3%
4/39 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
2.6%
1/38 • Number of events 1
|
5.1%
2/39 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
groin pain
|
0.00%
0/38
|
5.1%
2/39 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
limb discomfort
|
2.6%
1/38 • Number of events 1
|
25.6%
10/39 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal discomfort
|
0.00%
0/38
|
5.1%
2/39 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/38
|
10.3%
4/39 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
2.6%
1/38 • Number of events 1
|
15.4%
6/39 • Number of events 6
|
|
Nervous system disorders
headache
|
0.00%
0/38
|
10.3%
4/39 • Number of events 4
|
|
Nervous system disorders
paresthesia
|
0.00%
0/38
|
5.1%
2/39 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
pruritis
|
13.2%
5/38 • Number of events 5
|
7.7%
3/39 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
rash
|
2.6%
1/38 • Number of events 1
|
5.1%
2/39 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
7.9%
3/38 • Number of events 3
|
5.1%
2/39 • Number of events 2
|
|
Surgical and medical procedures
hematoma evacuation
|
0.00%
0/38
|
5.1%
2/39 • Number of events 2
|
|
Surgical and medical procedures
thrombectomy
|
0.00%
0/38
|
10.3%
4/39 • Number of events 4
|
|
Vascular disorders
deep vein thrombosis
|
0.00%
0/38
|
12.8%
5/39 • Number of events 5
|
|
Vascular disorders
venous thrombosis
|
0.00%
0/38
|
7.7%
3/39 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60