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Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities (017)

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ClinicalTrials.gov Identifier: NCT01197833
Recruitment Status : Completed
First Posted : September 9, 2010
Results First Posted : September 15, 2014
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Great Saphenous Vein Incompetence
Visible Varicosities
Interventions Drug: endovenous ablation+polidocanol injectable microfoam 0.125%
Drug: Endovenous ablation+polidocanol injectable microfoam 1.0%
Drug: Endovenous ablation+polidocanol injectable foam 2.0%
Enrollment 117
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Endovenous Ablation, Vehicle Placebo Endovenous Ablation, Polidocanol Injectable Foam, 0.5% Endovenous Ablation, Polidocanol Injectable Foam 1.0%
Hide Arm/Group Description Endovenous ablation followed by vehicle placebo Endovenous ablation followed by polidocanol injectable foam, 0.5% endovenous ablation followed by polidocanol injectable foam 1.0%
Period Title: Overall Study
Started 38 39 40
Completed 38 39 40
Not Completed 0 0 0
Arm/Group Title Endovenous Ablation, Vehicle Placebo Endovenous Ablation, Polidocanol Injectable Foam, 0.5% Endovenous Ablation, Polidocanol Injectable Foam 1.0% Total
Hide Arm/Group Description Endovenous ablation followed by vehicle placebo Endovenous ablation followed by polidocanol injectable foam, 0.5% endovenous ablation followed by polidocanol injectable foam 1.0% Total of all reporting groups
Overall Number of Baseline Participants 38 39 40 117
Hide Baseline Analysis Population Description
all treated patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 39 participants 40 participants 117 participants
54.1  (12.05) 50.1  (11.60) 51.8  (9.75) 52.0  (11.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 39 participants 40 participants 117 participants
Female
26
  68.4%
29
  74.4%
26
  65.0%
81
  69.2%
Male
12
  31.6%
10
  25.6%
14
  35.0%
36
  30.8%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg^m2
Number Analyzed 38 participants 39 participants 40 participants 117 participants
29.3  (6.04) 27.7  (4.58) 28.1  (5.25) 28.3  (5.32)
1.Primary Outcome
Title Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)
Hide Description 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.
Time Frame IPR-V3 measured at baseline and then at 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovenous Ablation, Vehicle Placebo Endovenous Ablation, Polidocanol Injectable Foam, 0.5% Endovenous Ablation, Polidocanol Injectable Foam 1.0%
Hide Arm/Group Description:
Endovenous ablation followed by vehicle placebo
Endovenous ablation followed by polidocanol injectable foam, 0.5%
endovenous ablation followed by polidocanol injectable foam 1.0%
Overall Number of Participants Analyzed 38 39 40
Least Squares Mean (Standard Error)
Unit of Measure: score
-0.80  (0.102) -1.30  (0.100) -1.11  (0.097)
2.Primary Outcome
Title Absolute Change From Baseline in PA-V3 Score
Hide Description 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 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)
Time Frame PA-V3 measured at baseline and then at 8 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Endovenous Ablation, Vehicle Placebo Endovenous Ablation, Polidocanol Injectable Foam, 0.5% Endovenous Ablation, Polidocanol Injectable Foam 1.0%
Hide Arm/Group Description:
Endovenous ablation followed by vehicle placebo
Endovenous ablation followed by polidocanol injectable foam, 0.5%
endovenous ablation followed by polidocanol injectable foam 1.0%
Overall Number of Participants Analyzed 38 39 40
Least Squares Mean (Standard Error)
Unit of Measure: score
-1.59  (0.142) -1.81  (0.140) -1.85  (0.136)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Endovenous Ablation, Vehicle Placebo Endovenous Ablation, Polidocanol Injectable Foam, 0.5% Endovenous Ablation, Polidocanol Injectable Foam 1.0%
Hide Arm/Group Description Endovenous ablation followed by vehicle placebo Endovenous ablation followed by polidocanol injectable foam, 0.5% endovenous ablation followed by polidocanol injectable foam 1.0%
All-Cause Mortality
Endovenous Ablation, Vehicle Placebo Endovenous Ablation, Polidocanol Injectable Foam, 0.5% Endovenous Ablation, Polidocanol Injectable Foam 1.0%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Endovenous Ablation, Vehicle Placebo Endovenous Ablation, Polidocanol Injectable Foam, 0.5% Endovenous Ablation, Polidocanol Injectable Foam 1.0%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      0/39 (0.00%)      0/40 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Endovenous Ablation, Vehicle Placebo Endovenous Ablation, Polidocanol Injectable Foam, 0.5% Endovenous Ablation, Polidocanol Injectable Foam 1.0%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/38 (52.63%)      29/39 (74.36%)      35/40 (87.50%)    
General disorders       
extravasation   1/38 (2.63%)  1 3/39 (7.69%)  3 2/40 (5.00%)  2
infusion site thrombosis   0/38 (0.00%)  0 3/39 (7.69%)  3 3/40 (7.50%)  3
edema peripheral   0/38 (0.00%)  0 1/39 (2.56%)  1 4/40 (10.00%)  4
tenderness   0/38 (0.00%)  0 0/39 (0.00%)  0 3/40 (7.50%)  3
Infections and infestations       
upper respiratory tract infection   1/38 (2.63%)  1 2/39 (5.13%)  2 0/40 (0.00%)  0
Injury, poisoning and procedural complications       
contusion   4/38 (10.53%)  4 7/39 (17.95%)  7 5/40 (12.50%)  5
excoriation   0/38 (0.00%)  0 2/39 (5.13%)  2 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorders       
arthralgia   2/38 (5.26%)  2 2/39 (5.13%)  2 0/40 (0.00%)  0
limb discomfort   2/38 (5.26%)  2 1/39 (2.56%)  1 2/40 (5.00%)  2
pain in extermity   11/38 (28.95%)  11 14/39 (35.90%)  14 11/40 (27.50%)  11
Nervous system disorders       
headache   1/38 (2.63%)  1 0/39 (0.00%)  0 2/40 (5.00%)  2
hypoaesthesia   0/38 (0.00%)  0 0/39 (0.00%)  0 2/40 (5.00%)  2
Skin and subcutaneous tissue disorders       
pruritis   2/38 (5.26%)  2 1/39 (2.56%)  1 4/40 (10.00%)  4
Vascular disorders       
deep vein thrombosis   1/38 (2.63%)  1 2/39 (5.13%)  2 0/40 (0.00%)  0
thrombophlebitis superficial   0/38 (0.00%)  0 13/39 (33.33%)  13 15/40 (37.50%)  15
thrombosis   0/38 (0.00%)  0 1/39 (2.56%)  1 2/40 (5.00%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: David Wright MB FRCS
Organization: BTG International Inc
Phone: 610-278-1660
Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01197833     History of Changes
Other Study ID Numbers: VAP.VV017
First Submitted: September 8, 2010
First Posted: September 9, 2010
Results First Submitted: February 7, 2014
Results First Posted: September 15, 2014
Last Update Posted: March 6, 2015