Treatment Trial for Post-Thrombotic Syndrome

Post Thrombotic Syndrome Clinical Trial

Official title:

A Randomized Trial to Determine the Impact of Lymphedema Therapy on Quality of Life and Disease Severity in Patients With Post-Thrombotic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633971
• Other study ID #: CHRMS 08-065
• Status: Completed
• Phase: N/A
• Start date: March 2008
• Est. completion date: September 2011

Study information

• Verified date: September 2020
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if complex lymphedema therapy is effective in decreasing disease severity and improving quality of life in patients with post thrombotic syndrome.

Description:

Post thrombotic syndrome (PTS) has a spectrum of disease manifestations ranging from minor skin discoloration to severe skin changes and venous ulcerations. Pain is often a prominent symptoms and PTS impairs patient quality of life. Prevention of PTS using compression stockings has been emphasized. There is a paucity of validated, effective treatments for PTS once the condition develops.

While the pathophysiology of PTS is incompletely understood, chronic venous hypertension and insufficiency may increase the workload of the lymphatic system and result in over-capacitance with secondary damage and eventual lymphatic insufficiency. In selected patients with PTS, we have noted a symptomatic improvement in patients who receive lymphedema therapy to the limb.

Complex lymphedema therapy (CLT) is a noninvasive treatment that includes four key components: meticulous skin care, manual lymph drainage, compression therapy, exercises and patient education for home management and continuation of the treatment. These techniques are designed to enhance lymph flow through intact cutaneous lymphatics and reduce swelling and restore function in the affected limb.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years.

• Diagnosis of post thrombotic syndrome.

• Median life expectancy of greater than 2 years.

• Previous history of lower extremity deep venous thrombosis.

Exclusion Criteria:

• Acute venous thrombosis of the lower extremity within the last 180 days.

• Unable to participate in lymphedema therapy due to monetary, physical or transportation limitations.

• Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• Pregnant women and women in their first post-partum month.

Related Conditions & MeSH terms

• Post Thrombotic Syndrome
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Syndrome

Intervention

Other:
• complex lymphedema therapy
Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy.

Locations

Country	Name	City	State
United States	Fletcher Allen Health Care; Department of Hematology/Oncology	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if complex lymphedema therapy improves the quality of life in patients with post-thrombotic syndrome		1 and 3 months
Primary	To determine if complex lymphedema therapy reduces disease severity in patients with post thrombotic syndrome		1 and 3 months
Secondary	To assess side effects of lymphedema therapy when administered to patients with PTS		1 and 3 months
Secondary	To determine if selected biomarkers correlate with disease severity and response to lymphedema therapy in patients with post thrombotic syndrome		1 and 3 months

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