Trial Outcomes & Findings for Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities (NCT NCT01197833)
NCT ID: NCT01197833
Last Updated: 2021-04-21
Results Overview
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 screening, the site clinician was instructed to review the appearance of the patient's varicose veins in the medial section of each leg (a 'live' assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient's varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient's visible varicose veins.
COMPLETED
PHASE3
117 participants
IPR-V3 measured at baseline and then at 8 weeks
2021-04-21
Participant Flow
Participant milestones
| Measure |
Endovenous Ablation, Vehicle Placebo
Endovenous ablation followed by vehicle placebo
|
Endovenous Ablation, Polidocanol Injectable Foam, 0.5%
Endovenous ablation followed by polidocanol injectable foam, 0.5%
|
Endovenous Ablation, Polidocanol Injectable Foam 1.0%
endovenous ablation followed by polidocanol injectable foam 1.0%
|
|---|---|---|---|
|
Overall Study
STARTED
|
38
|
39
|
40
|
|
Overall Study
COMPLETED
|
38
|
39
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
Baseline characteristics by cohort
| Measure |
Endovenous Ablation, Vehicle Placebo
n=38 Participants
Endovenous ablation followed by vehicle placebo
|
Endovenous Ablation, Polidocanol Injectable Foam, 0.5%
n=39 Participants
Endovenous ablation followed by polidocanol injectable foam, 0.5%
|
Endovenous Ablation, Polidocanol Injectable Foam 1.0%
n=40 Participants
endovenous ablation followed by polidocanol injectable foam 1.0%
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 12.05 • n=5 Participants
|
50.1 years
STANDARD_DEVIATION 11.60 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 11.18 • n=4 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
BMI
|
29.3 kg^m2
STANDARD_DEVIATION 6.04 • n=5 Participants
|
27.7 kg^m2
STANDARD_DEVIATION 4.58 • n=7 Participants
|
28.1 kg^m2
STANDARD_DEVIATION 5.25 • n=5 Participants
|
28.3 kg^m2
STANDARD_DEVIATION 5.32 • n=4 Participants
|
PRIMARY outcome
Timeframe: IPR-V3 measured at baseline and then at 8 weeksThe 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 screening, the site clinician was instructed to review the appearance of the patient's varicose veins in the medial section of each leg (a 'live' assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient's varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient's visible varicose veins.
Outcome measures
| Measure |
Endovenous Ablation, Vehicle Placebo
n=38 Participants
Endovenous ablation followed by vehicle placebo
|
Endovenous Ablation, Polidocanol Injectable Foam, 0.5%
n=39 Participants
Endovenous ablation followed by polidocanol injectable foam, 0.5%
|
Endovenous Ablation, Polidocanol Injectable Foam 1.0%
n=40 Participants
endovenous ablation followed by polidocanol injectable foam 1.0%
|
|---|---|---|---|
|
Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)
|
-0.80 score
Standard Error 0.102
|
-1.30 score
Standard Error 0.100
|
-1.11 score
Standard Error 0.097
|
PRIMARY outcome
Timeframe: PA-V3 measured at baseline and then at 8 weeksThe 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 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
| Measure |
Endovenous Ablation, Vehicle Placebo
n=38 Participants
Endovenous ablation followed by vehicle placebo
|
Endovenous Ablation, Polidocanol Injectable Foam, 0.5%
n=39 Participants
Endovenous ablation followed by polidocanol injectable foam, 0.5%
|
Endovenous Ablation, Polidocanol Injectable Foam 1.0%
n=40 Participants
endovenous ablation followed by polidocanol injectable foam 1.0%
|
|---|---|---|---|
|
Absolute Change From Baseline in PA-V3 Score
|
-1.59 score
Standard Error 0.142
|
-1.81 score
Standard Error 0.140
|
-1.85 score
Standard Error 0.136
|
Adverse Events
Endovenous Ablation, Vehicle Placebo
Endovenous Ablation, Polidocanol Injectable Foam, 0.5%
Endovenous Ablation, Polidocanol Injectable Foam 1.0%
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Endovenous Ablation, Vehicle Placebo
n=38 participants at risk
Endovenous ablation followed by vehicle placebo
|
Endovenous Ablation, Polidocanol Injectable Foam, 0.5%
n=39 participants at risk
Endovenous ablation followed by polidocanol injectable foam, 0.5%
|
Endovenous Ablation, Polidocanol Injectable Foam 1.0%
n=40 participants at risk
endovenous ablation followed by polidocanol injectable foam 1.0%
|
|---|---|---|---|
|
General disorders
extravasation
|
2.6%
1/38 • Number of events 1
|
7.7%
3/39 • Number of events 3
|
5.0%
2/40 • Number of events 2
|
|
General disorders
infusion site thrombosis
|
0.00%
0/38
|
7.7%
3/39 • Number of events 3
|
7.5%
3/40 • Number of events 3
|
|
General disorders
edema peripheral
|
0.00%
0/38
|
2.6%
1/39 • Number of events 1
|
10.0%
4/40 • Number of events 4
|
|
General disorders
tenderness
|
0.00%
0/38
|
0.00%
0/39
|
7.5%
3/40 • Number of events 3
|
|
Infections and infestations
upper respiratory tract infection
|
2.6%
1/38 • Number of events 1
|
5.1%
2/39 • Number of events 2
|
0.00%
0/40
|
|
Injury, poisoning and procedural complications
contusion
|
10.5%
4/38 • Number of events 4
|
17.9%
7/39 • Number of events 7
|
12.5%
5/40 • Number of events 5
|
|
Injury, poisoning and procedural complications
excoriation
|
0.00%
0/38
|
5.1%
2/39 • Number of events 2
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
5.3%
2/38 • Number of events 2
|
5.1%
2/39 • Number of events 2
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
limb discomfort
|
5.3%
2/38 • Number of events 2
|
2.6%
1/39 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
pain in extermity
|
28.9%
11/38 • Number of events 11
|
35.9%
14/39 • Number of events 14
|
27.5%
11/40 • Number of events 11
|
|
Nervous system disorders
headache
|
2.6%
1/38 • Number of events 1
|
0.00%
0/39
|
5.0%
2/40 • Number of events 2
|
|
Nervous system disorders
hypoaesthesia
|
0.00%
0/38
|
0.00%
0/39
|
5.0%
2/40 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
pruritis
|
5.3%
2/38 • Number of events 2
|
2.6%
1/39 • Number of events 1
|
10.0%
4/40 • Number of events 4
|
|
Vascular disorders
deep vein thrombosis
|
2.6%
1/38 • Number of events 1
|
5.1%
2/39 • Number of events 2
|
0.00%
0/40
|
|
Vascular disorders
thrombophlebitis superficial
|
0.00%
0/38
|
33.3%
13/39 • Number of events 13
|
37.5%
15/40 • Number of events 15
|
|
Vascular disorders
thrombosis
|
0.00%
0/38
|
2.6%
1/39 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place