Treatment Trial for Post-Thrombotic Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post Thrombotic Syndrome

Intervention / Treatment
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* Other: complex lymphedema therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Complex lymphedema therapy (which includes compression stocking use) | Other: complex lymphedema therapy<br>* Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy.<br>|
| Other: B<br>Standard of care (compression stocking use at 30-40 mm Hg) | Other: complex lymphedema therapy<br>* Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if complex lymphedema therapy improves the quality of life in patients with post-thrombotic syndrome |  | 1 and 3 months | 
| To determine if complex lymphedema therapy reduces disease severity in patients with post thrombotic syndrome |  | 1 and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post thrombotic syndrome, Thrombosis, Deep vein thrombosis, Venous thrombosis, Edema, stasis ulcers