Status:
COMPLETED
ESGVS: Sclerotherapy With Lauromacrogol
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Venous Insufficiency
Saphenous Vein
Eligibility:
All Genders
25-75 years
Phase:
PHASE3
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% L...
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 (G...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00348764
Start Date
March 1 2004
End Date
December 1 2006
Last Update
July 6 2006
Active Locations (1)
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1
Center of Vascular Medecine - 7 rue Lesdiguières
Grenoble, France, 38000