Pain, Erythema, Thrombus Length, Quality of Life
Conditions
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.
Interventions
OTHERno compression
no compression stockings worn during the study
DEVICEcompression
compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain assessed by VAS (cm) | at baseline, week 1, week 2, week 3 | change from baseline to week 3 at weekly intervals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| löwenberg test (mm Hg) | at baseline, week 1, week 2, week 3 | change from baseline to week 3 |
| skin erythema (cm2) | at baseline, week 1, week 2, week 3 | change from baseline to week 3 at weekly intervals |
| quality of life (SF-36) | at baseline and at week 3 | change from baseline to week 3 |
| amount of analgetics (number of pills) | week 1, week 2, week 3 | change from week 1 to week 3 |
| duplex-sonographic confirmation of deep vein thrombosis | at baseline and at week 3 | — |
| duplex-sonographic change in thrombus length (cm) | at baseline, week 1, week 2, week 3 | change from baseline to week 3 at weekly intervals |
Other
| Measure | Time frame |
|---|---|
| platelet count | at baseline, day 7 and day14 |
| D-dimer ug/ml | at baseline and at week 3 |
Outcome results
None listed