Compression Treatment of Superficial Vein Thrombosis
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
Leg compression is considered the basic treatment for superficial vein thrombosis (SVT). However, its use is more or less based on subjective experience while scientific evidence for its efficacy is lacking. There is one uncontrolled trial reporting improvement of clinical symptoms when patients with SVT were treated with fixed compression bandages. This study evaluates the efficacy of compression stockings (23-32 mmHg) in the treatment SVT of the legs. The investigators hypothesis is that compression treatment is superior to no compression in alleviating disease related clinical symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Dec 2009
Longer than P75 for not_applicable pain
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
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 6, 2013
CompletedJanuary 16, 2014
January 1, 2014
3.9 years
October 30, 2013
January 15, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
pain assessed by VAS (cm)
change from baseline to week 3 at weekly intervals
at baseline, week 1, week 2, week 3
Secondary Outcomes (6)
skin erythema (cm2)
at baseline, week 1, week 2, week 3
duplex-sonographic change in thrombus length (cm)
at baseline, week 1, week 2, week 3
quality of life (SF-36)
at baseline and at week 3
amount of analgetics (number of pills)
week 1, week 2, week 3
duplex-sonographic confirmation of deep vein thrombosis
at baseline and at week 3
- +1 more secondary outcomes
Other Outcomes (2)
D-dimer ug/ml
at baseline and at week 3
platelet count
at baseline, day 7 and day14
Study Arms (2)
no compression
EXPERIMENTALno compression stockings worn during a 3 weeks period
compression stockings
ACTIVE COMPARATORcompression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks
Interventions
compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks
Eligibility Criteria
You may qualify if:
- patients with superficial vein thrombosis of the leg,
- thrombus extent of at least 5 cm confirmed by duplex sonography,
- clinical signs of inflammation (pain, erythema)
You may not qualify if:
- superficial thrombus distance to the saphenofemoral or saphenopopliteal junction of less than 2cm,
- concomitant deep vein thrombosis,
- thrombophilia,
- active malignoma,
- immobility,
- peripheral arterial occlusive disease,
- superficial vein thrombosis after sclerotherapy
- incision and clot expression
- excessive leg configuration not covered by ready made compression stockings
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kornelia Böhler, MD
Medical University of Vienna, Department of General Dermatology
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
Study Record Dates
First Submitted
October 30, 2013
First Posted
November 6, 2013
Study Start
December 1, 2009
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
January 16, 2014
Record last verified: 2014-01