Compression Treatment of Superficial Vein Thrombosis
Primary Purpose
Pain, Erythema, Thrombus Length
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
no compression
compression
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
no compression
compression stockings
Arm Description
no compression stockings worn during a 3 weeks period
compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks
Outcomes
Primary Outcome Measures
pain assessed by VAS (cm)
change from baseline to week 3 at weekly intervals
Secondary Outcome Measures
skin erythema (cm2)
change from baseline to week 3 at weekly intervals
duplex-sonographic change in thrombus length (cm)
change from baseline to week 3 at weekly intervals
quality of life (SF-36)
change from baseline to week 3
amount of analgetics (number of pills)
change from week 1 to week 3
duplex-sonographic confirmation of deep vein thrombosis
löwenberg test (mm Hg)
change from baseline to week 3
Full Information
NCT ID
NCT01976637
First Posted
October 30, 2013
Last Updated
January 15, 2014
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01976637
Brief Title
Compression Treatment of Superficial Vein Thrombosis
Official Title
Compression Treatment of Superficial Vein Thrombosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Erythema, Thrombus Length, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no compression
Arm Type
Experimental
Arm Description
no compression stockings worn during a 3 weeks period
Arm Title
compression stockings
Arm Type
Active Comparator
Arm Description
compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks
Intervention Type
Other
Intervention Name(s)
no compression
Intervention Description
no compression stockings worn during the study
Intervention Type
Device
Intervention Name(s)
compression
Intervention Description
compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks
Primary Outcome Measure Information:
Title
pain assessed by VAS (cm)
Description
change from baseline to week 3 at weekly intervals
Time Frame
at baseline, week 1, week 2, week 3
Secondary Outcome Measure Information:
Title
skin erythema (cm2)
Description
change from baseline to week 3 at weekly intervals
Time Frame
at baseline, week 1, week 2, week 3
Title
duplex-sonographic change in thrombus length (cm)
Description
change from baseline to week 3 at weekly intervals
Time Frame
at baseline, week 1, week 2, week 3
Title
quality of life (SF-36)
Description
change from baseline to week 3
Time Frame
at baseline and at week 3
Title
amount of analgetics (number of pills)
Description
change from week 1 to week 3
Time Frame
week 1, week 2, week 3
Title
duplex-sonographic confirmation of deep vein thrombosis
Time Frame
at baseline and at week 3
Title
löwenberg test (mm Hg)
Description
change from baseline to week 3
Time Frame
at baseline, week 1, week 2, week 3
Other Pre-specified Outcome Measures:
Title
D-dimer ug/ml
Time Frame
at baseline and at week 3
Title
platelet count
Time Frame
at baseline, day 7 and day14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kornelia Böhler, MD
Organizational Affiliation
Medical University of Vienna, Department of General Dermatology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Compression Treatment of Superficial Vein Thrombosis
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