Overview

This trial is active, not recruiting.

Condition post thrombotic syndrome
Treatment complex lymphedema therapy
Phase phase 3
Sponsor University of Vermont
Start date March 2008
End date June 2010
Trial size 44 participants
Trial identifier NCT00633971, CHRMS 08-065

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Complex lymphedema therapy (which includes compression stocking use)
complex lymphedema therapy
Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy.
(Other)
Standard of care (compression stocking use at 30-40 mm Hg)
complex lymphedema therapy
Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy.

Primary Outcomes

Measure
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

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Chris E Holmes, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by University of Vermont.