Compression Treatment of Superficial Vein Thrombosis

Pain Clinical Trial

Official title:

Compression Treatment of Superficial Vein Thrombosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976637
• Other study ID #: EKNr 772/2009
• Status: Completed
• Phase: N/A
• First received: October 30, 2013
• Last updated: January 15, 2014
• Start date: December 2009
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erythema
• Pain
• Quality of Life
• Thrombosis
• Thrombus Length
• Venous Thrombosis

Intervention

Other:
• no compression
no compression stockings worn during the study

Device:
• compression
compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	D-dimer ug/ml		at baseline and at week 3
Other	platelet count		at baseline, day 7 and day14
Primary	pain assessed by VAS (cm)	change from baseline to week 3 at weekly intervals	at baseline, week 1, week 2, week 3
Secondary	skin erythema (cm2)	change from baseline to week 3 at weekly intervals	at baseline, week 1, week 2, week 3
Secondary	duplex-sonographic change in thrombus length (cm)	change from baseline to week 3 at weekly intervals	at baseline, week 1, week 2, week 3
Secondary	quality of life (SF-36)	change from baseline to week 3	at baseline and at week 3
Secondary	amount of analgetics (number of pills)	change from week 1 to week 3	week 1, week 2, week 3
Secondary	duplex-sonographic confirmation of deep vein thrombosis		at baseline and at week 3
Secondary	löwenberg test (mm Hg)	change from baseline to week 3	at baseline, week 1, week 2, week 3