Treatment Trial for Post-Thrombotic Syndrome - Full Text View

Sponsor:	University of Vermont
Information provided by:	University of Vermont
ClinicalTrials.gov Identifier:	NCT00633971

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.

Condition	Intervention	Phase
Post Thrombotic Syndrome	Other: complex lymphedema therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: lymphedema-distichiasis syndrome

MedlinePlus related topics: Deep Vein Thrombosis Lymphedema

U.S. FDA Resources

Further study details as provided by University of Vermont:

Primary Outcome Measures:

To determine if complex lymphedema therapy improves the quality of life in patients with post-thrombotic syndrome [ Time Frame: 1 and 3 months ] [ Designated as safety issue: No ]
To determine if complex lymphedema therapy reduces disease severity in patients with post thrombotic syndrome [ Time Frame: 1 and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess side effects of lymphedema therapy when administered to patients with PTS [ Time Frame: 1 and 3 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	44
Study Start Date:	March 2008
Estimated Study Completion Date:	September 2011
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A Complex lymphedema therapy (which includes compression stocking use)	Other: complex lymphedema therapy Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy.
B Standard of care (compression stocking use at 30-40 mm Hg)	Other: complex lymphedema therapy Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633971

Locations

United States, Vermont
Fletcher Allen Health Care; Department of Hematology/Oncology
Burlington, Vermont, United States, 05401

Sponsors and Collaborators

University of Vermont

Investigators

Principal Investigator:

Chris E Holmes, MD, PhD

University of Vermont and Fletcher Allen Health Care

More Information

Additional Information:

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No publications provided

Responsible Party:	Chris E. Holmes, M.D., Ph.D. Assistant Professor, Department of Medicine, University of Vermont- Fletcher Allen Health Care
ClinicalTrials.gov Identifier:	NCT00633971 History of Changes
Other Study ID Numbers:	CHRMS 08-065
Study First Received:	March 4, 2008
Last Updated:	April 21, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Vermont:

Post thrombotic syndrome
Thrombosis
Deep vein thrombosis

Venous thrombosis
Edema
stasis ulcers

Additional relevant MeSH terms:

Postthrombotic Syndrome
Postphlebitic Syndrome
Thrombosis
Venous Thrombosis
Embolism and Thrombosis

Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on February 12, 2012