Compression Treatment of Superficial Vein Thrombosis

N/ACompletedNCT01976637

Medical University of Vienna80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain Erythema Thrombus Length Quality of Life

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

pain assessed by VAS (cm)

change from baseline to week 3 at weekly intervals

Time frame: at baseline, week 1, week 2, week 3

Secondary Outcomes

skin erythema (cm2)

change from baseline to week 3 at weekly intervals

Time frame: at baseline, week 1, week 2, week 3

duplex-sonographic change in thrombus length (cm)

change from baseline to week 3 at weekly intervals

Time frame: at baseline, week 1, week 2, week 3

quality of life (SF-36)

change from baseline to week 3

Time frame: at baseline and at week 3

amount of analgetics (number of pills)

change from week 1 to week 3

Time frame: week 1, week 2, week 3

duplex-sonographic confirmation of deep vein thrombosis

Time frame: at baseline and at week 3

löwenberg test (mm Hg)

change from baseline to week 3

Time frame: at baseline, week 1, week 2, week 3