Treatment Trial for Post-Thrombotic Syndrome

Not Applicable

Completed

• Conditions: Post Thrombotic Syndrome
• Interventions: Other: complex lymphedema therapy

• Registration Number: NCT00633971
• Lead Sponsor: University of Vermont

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 Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-12
• Primary Completion: 2010-06
• Study Completion: 2011-09
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-15
• Last Update Posted: 2020-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	complex lymphedema therapy	Standard of care (compression stocking use at 30-40 mm Hg)
A	complex lymphedema therapy	Complex lymphedema therapy (which includes compression stocking use)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Fletcher Allen Health Care; Department of Hematology/Oncology; 🇺🇸 Burlington, Vermont, United States