Venous Insufficiency, Saphenous Vein
Conditions
Keywords
lauromacrogol, Sclerotherapy
Brief summary
To evaluate the efficacy and the tolerance of echoguided sclerotherapy using Lauromacrogol 400 foam for the treatment of Great Saphenous Vein (GSV) insufficiency. A comparative study of 3% versus 1% Lauromacrogol 400 foam.
Detailed description
A multicenter randomized double blind study to evaluate the efficacy and the tolerance of echoguided sclerotherapy using 3% versus 1% Lauromacrogol 400 foam in the treatment of Great Saphenous Vein (GSV) insufficiency. One hundred fifty eligible patients will be recruited during 6 months from 9 study centers with a follow up period of 3 years and 7 visits at day 8, 6 weeks, 3 months, 6 months, 1,2 ,and 3 years. After randomization, the patients will be treated by echoguided sclerotherapy with 1% or 3% Lauromacrogol 400 foam (ratio 1:1). Monitoring is performed by doppler at 8 days, 6 weeks, 6 months , 1,2 ,and 3 years. Effectiveness of sclerotherapy is determined at 6 weeks, 3 months and 6 months. A additional injection of 4 ml of foam can be performed if needed. Severity clinical score and Quality-of-life questionnaire are performed at 6 months ,1 ,2, and 3 years. The absence of obliteration with a reflux of crural great saphenous vein at 6 months will be a criterion of therapeutic failure. The therapeutic success or failure criteria are evaluated by a non investigator angiologist for 5 patients randomized from each investigational site at 1, 2 and 3 years.
Interventions
DRUGlauromacrogol
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 25 - 75 years * Hawaii CEAP classification : C2-5 Ep, As2-3 Pr * Clinical Varicose veins C2, Edema C3, Skin changes C4, Healed ulcer C5 * Etiology Ep Primary GSV insufficiency * As2-3: Ostial and or crural truncular GVS incompetence * Maximal inferior diameter of the leg GSV (patient in decubitus) between 4 and 8mm * Pr: reflux by echo doppler in orthostatism \> 1 second * Information consent form signed by the investigator and the patient.
Exclusion criteria
* deep venous reflux (CEAP: Ad) * Short saphenous vein or non saphenous network insufficiency (CEAP: A4-5) * Clinical class: C1 or C6 * Recurrent GSV varicose veins after stripping * Thrombophilia or antecedent of deep vein thrombosis * Psychiatric disorders * Known allergy to Lauromacrogol or to one of its component * Arteriopathy. (IPS \< 0.8) * Post-thrombotic disease * Chronic hepatoma * Renal insufficiency (creatinine \> 150 micromol/l)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of sus gonal saphenous reflux > 1 second. | — |
Secondary
| Measure | Time frame |
|---|---|
| Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of sus gonal saphenous reflux > 1 second. | — |
Countries
France
Outcome results
None listed