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FOAM-study, Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01103258
First received: April 6, 2010
Last updated: April 12, 2010
Last verified: April 2010
  Purpose

Varicose vein disease is a common health problem, which causes much discomfort to patients.

Nowadays treatment modalities for greater saphenous veins include surgery and duplex guided foam sclerotherapy. These are two equally accepted and applied treatments for the same patient population.

Choice of treatment often depends on the referral preference of the General Practitioner. Until now data are missing which treatment is more cost effective. The current proposal aims at comparing the effects, costs and patient preferences between duplex guided foam sclerotherapy and surgery in the treatment of greater varicose veins.


Condition Intervention
Varicose Vein Disease
Procedure: high ligation and stripping (surgery)
Procedure: FOAM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FOAM-study Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins: a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • cumulative probability of recurrent varicose vein within 24 months after treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life (as measured by EuroQol-5D) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • patient preferences (as measured by conjoint analysis) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • direct Health care costs [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    materials, operation costs, personnel costs


Enrollment: 460
Study Start Date: February 2006
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: high ligation and stripping
surgery consisting of high ligation in combination with long saphenous stripping
Procedure: high ligation and stripping (surgery)
surgery consisting of high ligation in combination with long saphenous stripping
Active Comparator: duplex guided foam sclerotherapy
duplex guided foam sclerotherapy
Procedure: FOAM
duplex guided foam sclerotherapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • incompetence of great saphenous vein for minimal 20 cm
  • life expectancy at least 3 years
  • open and competent deep venous system
  • willing to undergo both treatments

Exclusion Criteria:

  • active ulcer
  • signs of deep venous thrombosis with duplex
  • incompetence of the deep venous system
  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: NCT01103258

Locations
Netherlands
Maastricht UMC
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Director: A Sommer, MD PhD Maastricht UMC
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr A Sommer, Maastricht UMC
ClinicalTrials.gov Identifier: NCT01103258     History of Changes
Other Study ID Numbers: MEC 05-2-014, ZON MW 4636
Study First Received: April 6, 2010
Last Updated: April 12, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Incompetence of the great saphenous vein.

Additional relevant MeSH terms:
Varicose Veins
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014