Venous Insufficiency Clinical Trial
Official title:
Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux - A Randomized Controlled Trial
Verified date | October 2012 |
Source | Helsinki University Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Institutional Review Board |
Study type | Interventional |
Randomized controlled trial, a method used to implement the random allocation sequence is
numbered containers.
The aim of the study is to compare compression therapy with compression stockings and
surgery eliminating superficial venous reflux in patients with duplex ultrasound verified
superficial venous reflux without skin changes or ulceration.
Status | Completed |
Enrollment | 153 |
Est. completion date | September 2012 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 70 Years |
Eligibility |
Inclusion Criteria: - patients with chronic superficial vein insufficiency - patient must be 20-70 years old - degree of difficulty of vein insufficiency C2-C3 - venous disability score 1-2 - patient is agreeable to the study Exclusion Criteria: - peripheral atherosclerotic occlusive disease - lymphoedema - severe concomitant disease (ASA 3-5) - venous ulcers or unclassified skin changes - BMI more than 35 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Finland | Department of Vascular Surgery, Helsinki University Central Hospital | Helsinki | HUS |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom relief | Patients are examined at the baseline, one and 2-year follow-up and the following measures are compared: clinical classification, venous disability score, venous disease severity score, reflux according to ultrasound examination. | two years | No |
Secondary | Quality of life | Quality of life is evaluated with two questionnaires: Aberdeen (which is a 13-item questionnaire with categories related specially to disadvantages caused by varicose veins) and 15D (a questionnaire with categories related to general quality of life). | two years | No |
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