Expired Study
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Burlington, Vermont 05401


Purpose:

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.


Study 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.


Criteria:

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.


Study is Available At:


Original ID:

CHRMS 08-065


NCT ID:

NCT00633971


Secondary ID:


Study Acronym:


Brief Title:

Treatment Trial for Post-Thrombotic Syndrome


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


Overall Status:

Active, not recruiting


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Vermont


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

44


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Chris E Holmes, MD, PhD
Principal Investigator
University of Vermont and Fletcher Allen Health Care

Study Dates

Start Date:March 2008
Completion Date:September 2011
Completion Type:Anticipated
Primary Completion Date:June 2010
Primary Completion Type:Actual
Verification Date:April 2011
Last Changed Date:April 21, 2011
First Received Date:March 4, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To assess side effects of lymphedema therapy when administered to patients with PTS
Time Frame:1 and 3 months
Safety Issues:True
Outcome Type:Primary Outcome
Measure:To determine if complex lymphedema therapy reduces disease severity in patients with post thrombotic syndrome
Time Frame:1 and 3 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To determine if complex lymphedema therapy improves the quality of life in patients with post-thrombotic syndrome
Time Frame:1 and 3 months
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:complex lymphedema therapy
Description:Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy.
Arm Name:A

Study Arms

Study Arm Type:Other
Arm Name:B
Description:Standard of care (compression stocking use at 30-40 mm Hg)
Study Arm Type:Experimental
Arm Name:A
Description:Complex lymphedema therapy (which includes compression stocking use)

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Vermont

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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