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Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study

Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02304146
Enrollment
460
Registered
2014-12-01
Start date
2014-11-30
Completion date
2015-10-31
Last updated
2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose Veins

Keywords

Foam, UGFS, Stripping, Incompetence

Brief summary

The aim of this study is to investigate the long-term follow-up of the previously conducted FOAM study.

Detailed description

It describes the long-term quality of life (QoL) after ultrasound guided foam sclerotherapy (UGFS) and surgical stripping, outcomes with regard to clinical, and ultrasound recurrence, progression of venous disease, predictive value of the presence of central / deep venous obstruction for recurrence of varicose veins and the long term cost analysis. Recurrence of varicose veins was defined as the presence of one or more venous symptoms such as pain, cramps, restless legs and a tired/heavy feeling in the treated leg, in combination with the presence of reflux longer than 0·5 s. The initial definition of recurrent reflux, which is defined as reflux for more than 2 cm in length in the treated vein segment (proximal great saphenous vein (GSV) ) as measured by colour flow duplex ultrasound (DUS). DUS findings of the treated proximal GSV were categorized as: 1, absence of reflux; 2, reflux; 3, occlusion; 4, partial occlusion with reflux; 5, absence of vein, is being used. Patients in categories 2 and 4 are considered to have reflux.

Interventions

None listed

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* all patients included in previous FOAM study

Exclusion criteria

* no received informed consent

Design outcomes

Primary

MeasureTime frame
long-term QoL follow-up of patients after UGFS and surgical stripping6-10 years follow-up

Secondary

MeasureTime frameDescription
Clinical recurrence6-10 years follow-up
Technical recurrence6-10 years follow-upVein closure rates
Number of retreatments6-10 years follow-up
Venous Clinical Severity Score change6-10 years follow-up

Countries

Netherlands

Contacts

Primary ContactYee Lai Lam, M.D.
y.lam@maastrichtuniversity.nl+31433881472

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026