Compression Therapy Versus Surgery in the Treatment of Superficial Venous Reflux
1 other identifier
interventional
153
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 3, 2012
CompletedFirst Posted
Study publicly available on registry
October 5, 2012
CompletedOctober 5, 2012
October 1, 2012
4.1 years
October 3, 2012
October 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Quality of life
two years
Study Arms (2)
conservative treatment
ACTIVE COMPARATORCompression stockings class II
Operative treatment
ACTIVE COMPARATORstripping of main trunk or if previously removed, removal or ligating the refloating trunk
Interventions
stripping of main trunk or if previously removed, removal or ligating the refluating trunk
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- peripheral atherosclerotic occlusive disease
- lymphoedema
- severe concomitant disease (ASA 3-5)
- venous ulcers or unclassified skin changes
- BMI more than 35
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Vascular Surgery, Helsinki University Central Hospital
Helsinki, HUS, 00029, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maarit Venermo, MD,PhD
Department of Vascular Surgery, Helsinki University Central Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,PhD
Study Record Dates
First Submitted
October 3, 2012
First Posted
October 5, 2012
Study Start
September 1, 2004
Primary Completion
October 1, 2008
Study Completion
September 1, 2012
Last Updated
October 5, 2012
Record last verified: 2012-10