Varicose Veins Clinical Trial
Official title:
Long-term Ultrasound Guided Foam Sclerotherapy Versus Classical Surgical Stripping Study
The aim of this study is to investigate the long-term follow-up of the previously conducted FOAM study.
Status | Recruiting |
Enrollment | 460 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - all patients included in previous FOAM study Exclusion Criteria: - no received informed consent |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Netherlands | Department of Dermatology, Atrium Medical Centre. | Heerlen | Limburg |
Netherlands | Maastricht UMC+ | Maastricht | Limburg |
Netherlands | Departments of Dermatology and Surgery, Laurentius Hospital | Roermond | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Shadid N, Ceulen R, Nelemans P, Dirksen C, Veraart J, Schurink GW, van Neer P, vd Kley J, de Haan E, Sommer A. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg. 2012 Aug;9 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | long-term QoL follow-up of patients after UGFS and surgical stripping | 6-10 years follow-up | No | |
Secondary | Clinical recurrence | 6-10 years follow-up | No | |
Secondary | Technical recurrence | Vein closure rates | 6-10 years follow-up | No |
Secondary | Number of retreatments | 6-10 years follow-up | No | |
Secondary | Venous Clinical Severity Score change | 6-10 years follow-up | No |
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