ESGVS: Sclerotherapy With Lauromacrogol

Phase 3

Completed

• Conditions: Venous Insufficiency; Saphenous Vein

• Registration Number: NCT00348764
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study Start: 2004-03
• Status Verified: 2006-07
• Study First Submitted: 2006-07-05
• Study First Submitted QC: 2006-07-05
• Last Update Submitted: 2006-07-05
• Study First Posted: 2006-07-06
• Last Update Posted: 2006-07-06
• Study Completion: 2006-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of "sus gonal" saphenous reflux > 1 second.

Secondary Outcome Measures

Name	Time	Method
Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of "sus gonal" saphenous reflux > 1 second.

Trial Locations

Locations (1)

Center of Vascular Medecine - 7 rue Lesdiguières; 🇫🇷 Grenoble, France