NCT00348764

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 6, 2006

Status Verified

July 1, 2006

First QC Date

July 5, 2006

Last Update Submit

July 5, 2006

Conditions

Venous InsufficiencySaphenous Vein

Keywords

lauromacrogolSclerotherapy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

lauromacrogolDRUG

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Vascular Medecine - 7 rue Lesdiguières

Grenoble, 38000, France

Location

Related Publications (5)

  • Bosson JL, Riachi M, Pichot O, Michoud E, Carpentier PH, Franco A. Diameters of acute proximal and distal deep venous thrombosis of the lower limbs. Int Angiol. 1998 Dec;17(4):260-7.

    PMID: 10204659BACKGROUND

  • Ferretti GR, Bosson JL, Buffaz PD, Ayanian D, Pison C, Blanc F, Carpentier F, Carpentier P, Coulomb M. Acute pulmonary embolism: role of helical CT in 164 patients with intermediate probability at ventilation-perfusion scintigraphy and normal results at duplex US of the legs. Radiology. 1997 Nov;205(2):453-8. doi: 10.1148/radiology.205.2.9356628.

    PMID: 9356628BACKGROUND

  • Barro C, Bosson JL, Pernod G, Carpentier PH, Polack B. Plasma D-dimer testing improves the management of thromboembolic disease in hospitalized patients. Thromb Res. 1999 Sep 1;95(5):263-9. doi: 10.1016/s0049-3848(99)00042-0. No abstract available.

    PMID: 10515291BACKGROUND

  • Bosson JL, Labarere J, Sevestre MA, Belmin J, Beyssier L, Elias A, Franco A, Le Roux P. Deep vein thrombosis in elderly patients hospitalized in subacute care facilities: a multicenter cross-sectional study of risk factors, prophylaxis, and prevalence. Arch Intern Med. 2003 Nov 24;163(21):2613-8. doi: 10.1001/archinte.163.21.2613.

    PMID: 14638561BACKGROUND

  • Bosson JL, Labarere J, Barrellier MT, Belmin J, Couturier P, Le Roux P, Sevestre MA; Association pour la Promotion de l'Angiologie Hospitaliere (APAH). [Practice guidelines for the prevention of venous thromboembolism in elderly patients hospitalized in subacute care and rehabilitation facilities (short text). Association for the Promotion of Hospital Angiology]. J Mal Vasc. 2003 Oct;28(4):209-18. No abstract available. French.

    PMID: 14618112BACKGROUND

MeSH Terms

Conditions

Venous Insufficiency

Interventions

Polidocanol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsEthylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • DIAMAND Jean Marc

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 6, 2006

Study Start

March 1, 2004

Study Completion

December 1, 2006

Last Updated

July 6, 2006

Record last verified: 2006-07

Locations

FR(1)