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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
ClinicalTrials.gov Identifier:
First Posted: March 12, 2008
Last Update Posted: April 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Vermont
March 4, 2008
March 12, 2008
April 22, 2011
March 2008
June 2010   (Final data collection date for 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 ]
  • To determine if complex lymphedema therapy reduces disease severity in patients with post thrombotic syndrome [ Time Frame: 1 and 3 months ]
Same as current
Complete list of historical versions of study NCT00633971 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Treatment Trial for Post-Thrombotic Syndrome
A Randomized Trial to Determine the Impact of Lymphedema Therapy on Quality of Life and Disease Severity in Patients With Post-Thrombotic Syndrome
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.

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Post Thrombotic Syndrome
Other: complex lymphedema therapy
Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy.
  • Experimental: A
    Complex lymphedema therapy (which includes compression stocking use)
    Intervention: Other: complex lymphedema therapy
  • B
    Standard of care (compression stocking use at 30-40 mm Hg)
    Intervention: Other: complex lymphedema therapy
Holmes CE, Bambace NM, Lewis P, Callas PW, Cushman M. Efficacy of a short course of complex lymphedema therapy or graduated compression stocking therapy in the treatment of post-thrombotic syndrome. Vasc Med. 2014 Feb;19(1):42-8. doi: 10.1177/1358863X14521883.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
September 2011
June 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CHRMS 08-065
Not Provided
Not Provided
Chris E. Holmes, M.D., Ph.D. Assistant Professor, Department of Medicine, University of Vermont- Fletcher Allen Health Care
University of Vermont
Not Provided
Principal Investigator: Chris E Holmes, MD, PhD University of Vermont and Fletcher Allen Health Care
University of Vermont
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP