ESGVS: Sclerotherapy With Lauromacrogol

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00348764
First received: July 5, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Venous Insufficiency
Saphenous Vein
Drug: lauromacrogol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment of Greater Saphenous Vein (GSV) Insufficiency Using Echo-Guided Sclerotherapy With Lauromacrogol 400 Foam –Comparative Study of 3% Versus 1% Concentration.

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of “sus gonal” saphenous reflux > 1 second.

Secondary Outcome Measures:
  • Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of “sus gonal” saphenous reflux > 1 second.

Estimated Enrollment: 150
Study Start Date: March 2004
Estimated Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348764

Locations
France
Center of Vascular Medecine - 7 rue Lesdiguières
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: DIAMAND Jean Marc Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00348764     History of Changes
Other Study ID Numbers: DCIC 03 38
Study First Received: July 5, 2006
Last Updated: July 5, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
lauromacrogol
Sclerotherapy

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014