Treatment of Greater Saphenous Vein (GSV) Insufficiency Using Echo-Guided Sclerotherapy With Lauromacrogol 400 Foam -Comparative Study of 3% Versus 1% Concentration.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of "sus gonal" saphenous reflux > 1 second.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 25 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Outcomes
Primary Outcomes
Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of "sus gonal" saphenous reflux > 1 second.
Secondary Outcomes
- Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of "sus gonal" saphenous reflux > 1 second.