ESGVS: Sclerotherapy With Lauromacrogol

Venous Insufficiency Clinical Trial

Official title:

Treatment of Greater Saphenous Vein (GSV) Insufficiency Using Echo-Guided Sclerotherapy With Lauromacrogol 400 Foam –Comparative Study of 3% Versus 1% Concentration.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348764
• Other study ID #: DCIC 03 38
• Status: Completed
• Phase: Phase 3
• First received: July 5, 2006
• Last updated: July 5, 2006
• Start date: March 2004
• Est. completion date: December 2006

Study information

• Verified date: July 2006
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Saphenous Vein
• Venous Insufficiency

Intervention

Drug:
• lauromacrogol

Locations

Country	Name	City	State
France	Center of Vascular Medecine - 7 rue Lesdiguières	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

Bosson JL, Labarère J, Barrellier MT, Belmin J, Couturier P, Le Roux P, Sevestre MA; Association pour la Promotion de l'Angiologie Hospitalière (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. French. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of “sus gonal” saphenous reflux > 1 second.
Secondary	Removal of truncular GSV incompetence evaluated at 6 months by echo doppler: no persistence of “sus gonal” saphenous reflux > 1 second.