Varicose Veins
Conditions
Keywords
Varicose Veins
Brief summary
The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the treatment of varicose veins compared to placebo.
Detailed description
The purpose of this study is to evaluate the efficacy of polidocanol injectable foam vs placebo treatments in relief of symptoms using two disease specific questionnaires, establishment of a minimally important difference (MID) for the questionnaires, improvement in the appearance of visible varicosities by a patient and medical assessments aided by pre and post treatment photographs, and a central independent assessor evaluating pre and post treatment photographs. In addition, the study will evaluate the efficacy of polidocanol injectable foam vs the placebo treatment in the elimination of SFJ reflux or occlusion of the treated vein, and to determine whether the placebo procedure blinds the patient to treatment assignment.
Interventions
DRUGVarisolve (Polidocanol Endovenous Microfoam)
1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2)
DRUGAgitated Saline
10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Males and Females 18-65 years old * VEINES Sym Score less than 75 points * Varicose Vein clinical classification CEAP 2, 3, 4, or 5 * Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein * Superficial venous disease manifested by both symptoms and visible varicosities * Ability to comprehend and sign an informed consent document and completed study questionnaires in English
Exclusion criteria
* Incompetence of the SSV which substantially contributes to the filling of visible varicose veins * Current or previous Deep Vein Thrombosis * Leg obesity * Peripheral arterial disease in the leg to be treated * Reduced mobility * Planned prolonged travel with limited mobility with in 4 weeks of treatment * History of pulmonary embolism or stroke * Major surgery, prolonged hospitalization or pregnancy within 3 months * Current anticoagulation therapy (within 7 days of enrollment) * Participation in a clinical study involving a investigational product within 3 months * Major co-existing disease or clinically significant laboratory abnormalities * Known allergic response to polidocanol or heparin or severe and/or multiple allergic reactions * Women of childbearing potential not using effective contraception one month prior to enrollment and/or unwilling to continue while on study * Pregnant or lactating women * Current alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks | Baseline to 8 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Agitated Saline: 10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session | 38 |
| Polidocanol Injectable Foam, 1.0% Polidocanol injectable foam 1%, up to 15 mL, one treatment session | 39 |
| Total | 77 |
Baseline characteristics
| Characteristic | Polidocanol Injectable Foam, 1.0% | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 10.75 | 45.1 years STANDARD_DEVIATION 10.66 | 44.9 years STANDARD_DEVIATION 10.71 |
| Baseline VCSS | 6.6 units on a scale STANDARD_DEVIATION 2.05 | 6.3 units on a scale STANDARD_DEVIATION 2.01 | 6.0 units on a scale STANDARD_DEVIATION 1.95 |
| CEAP Clinical classification C3 - Edema | 35 participants | 69 participants | 34 participants |
| CEAP Clinical classification C4 - Skin Change Without Ulceration | 2 participants | 6 participants | 4 participants |
| CEAP Clinical classification C5 - Skin Change With Healed Ulceration | 2 participants | 2 participants | 0 participants |
| Sex: Female, Male Female | 30 Participants | 62 Participants | 32 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 6 Participants |
| VEINES-Sym Score | 59.3 units on a scale STANDARD_DEVIATION 26.11 | 60.6 units on a scale STANDARD_DEVIATION 25.94 | 61.9 units on a scale STANDARD_DEVIATION 26.05 |
| VVSymQ Score | 52.6 units on a scale STANDARD_DEVIATION 29.37 | 55.0 units on a scale STANDARD_DEVIATION 28.6 | 57.5 units on a scale STANDARD_DEVIATION 27.97 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 38 | 36 / 39 |
| serious Total, serious adverse events | 1 / 38 | 1 / 39 |
Outcome results
Primary
The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks
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.
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks | 16.7 units on a scale | Standard Error 3.18 |
| Polidocanol Injectable Foam, 1.0% | The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks | 30.7 units on a scale | Standard Error 3.04 |