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Treatment Trial for Post-Thrombotic Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Vermont.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Vermont
ClinicalTrials.gov Identifier:
NCT00633971
First received: March 4, 2008
Last updated: April 21, 2011
Last verified: April 2011

March 4, 2008
April 21, 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 ] [ 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 ]
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 ] [ 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 ]
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.
 
Active, not recruiting
44
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00633971
CHRMS 08-065
No
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