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

April 12, 2010 updated by: Maastricht University Medical Center

FOAM-study Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins: a Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

460

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Procedure: FOAM
duplex guided foam sclerotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cumulative probability of recurrent varicose vein within 24 months after treatment
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life (as measured by EuroQol-5D)
Time Frame: 24 months
24 months
patient preferences (as measured by conjoint analysis)
Time Frame: 24 months
24 months
direct Health care costs
Time Frame: 24 months
materials, operation costs, personnel costs
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Study Director: A Sommer, MD PhD, Maastricht UMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

April 6, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 14, 2010

Study Record Updates

Last Update Posted (Estimate)

April 14, 2010

Last Update Submitted That Met QC Criteria

April 12, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 05-2-014
  • ZON MW 4636 (Other Grant/Funding Number: ZON MW)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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