ESGVS: Sclerotherapy With Lauromacrogol

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Treatments: Polidocanol

Criteria

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)