Overview

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)