Clinical Trial: Treatment Trial for Post-Thrombotic Syndrome
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
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
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 Summary:
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.
Sponsor: University of Vermont
Current 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 ]
Original Primary Outcome: Same as current
Current 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 ]
Original Secondary Outcome: Same as current
Information By: University of Vermont
Dates:
Date Received: March 4, 2008
Date Started: March 2008
Date Completion: September 2011
Last Updated: April 21, 2011
Last Verified: April 2011
