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Treatment Trial for Post-Thrombotic Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2011 by University of Vermont.
Recruitment status was:  Active, not recruiting
Information provided by:
University of Vermont Identifier:
First received: March 4, 2008
Last updated: April 21, 2011
Last verified: April 2011
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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 ]
  • To determine if complex lymphedema therapy reduces disease severity in patients with post thrombotic syndrome [ Time Frame: 1 and 3 months ]

Secondary Outcome Measures:
  • 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 ]

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.
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00633971

United States, Vermont
Fletcher Allen Health Care; Department of Hematology/Oncology
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Principal Investigator: Chris E Holmes, MD, PhD University of Vermont and Fletcher Allen Health Care
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chris E. Holmes, M.D., Ph.D. Assistant Professor, Department of Medicine, University of Vermont- Fletcher Allen Health Care Identifier: NCT00633971     History of Changes
Other Study ID Numbers: CHRMS 08-065
Study First Received: March 4, 2008
Last Updated: April 21, 2011

Keywords provided by University of Vermont:
Post thrombotic syndrome
Deep vein thrombosis
Venous thrombosis
stasis ulcers

Additional relevant MeSH terms:
Postthrombotic Syndrome
Postphlebitic Syndrome
Pathologic Processes
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Peripheral Vascular Diseases processed this record on May 22, 2017