A Randomized Trial to Determine the Impact of Lymphedema Therapy on Quality of Life and Disease Severity in Patients With Post-Thrombotic Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Vermont
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- To determine if complex lymphedema therapy improves the quality of life in patients with post-thrombotic syndrome
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
A
Complex lymphedema therapy (which includes compression stocking use)
Intervention: complex lymphedema therapy (Other)
B
Standard of care (compression stocking use at 30-40 mm Hg)
Intervention: complex lymphedema therapy (Other)
Outcomes
Primary Outcomes
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 Outcomes
- To assess side effects of lymphedema therapy when administered to patients with PTS(1 and 3 months)
- To determine if selected biomarkers correlate with disease severity and response to lymphedema therapy in patients with post thrombotic syndrome(1 and 3 months)
Investigators
Chris Holmes
Associate Professor of Medicine
University of Vermont