Condition(s) treated: Post Thrombotic Syndrome

Intervention: complex lymphedema therapy (Other)

Phase: Phase 3

Enrollment status: Recruiting

Sponsor: University of Vermont

Principal investigator(s) or official(s):
Chris E Holmes, MD, PhD, Principal Investigator, Affiliation: University of Vermont and Fletcher Allen Health Care

Overall contact:
Chris E Holmes, MD, PhD, Phone: 802-847-8400, Email: chris.holmes@uvm.edu

The purpose of our 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.

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

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:
To determine if complex lymphedema therapy improves the quality of life in patients with post-thrombotic syndrome (Time Frame: 1 and 3 months)

To determine if complex lymphedema therapy reduces disease severity in patients with post thrombotic syndrome (Time Frame: 1 and 3 months)

Secondary outcome:
To assess side effects of lymphedema therapy when administered to patients with PTS (Time Frame: 1 and 3 months)

To determine if selected biomarkers correlate with disease severity and response to lymphedema therapy in patients with post thrombotic syndrome (Time Frame: 1 and 3 months)

Detailed 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.

Minimum eligible age: 18 Years. Eligible gender(s): Both.

Criteria:

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.

Chris E Holmes, MD, PhD, Phone: 802-847-8400, Email: chris.holmes@uvm.edu

Fletcher Allen Health Care; Department of Hematology/Oncology, Burlington, Vermont 05401, United States; Recruiting
Chris E Holmes, MD, PhD, Phone: 802-847-8400, Email: chris.holmes@uvm.edu

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Start date: March 2008
End date: February 2009
Last updated: March 11, 2008

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