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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014