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.

Study Overview

• Status: Completed
• Conditions: Post Thrombotic Syndrome
• Intervention / Treatment: Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine if complex lymphedema therapy improves the quality of life in patients with post-thrombotic syndrome	1 and 3 months
To determine if complex lymphedema therapy reduces disease severity in patients with post thrombotic syndrome	1 and 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess side effects of lymphedema therapy when administered to patients with PTS	1 and 3 months
To determine if selected biomarkers correlate with disease severity and response to lymphedema therapy in patients with post thrombotic syndrome	1 and 3 months

Collaborators and Investigators

• Sponsor: University of Vermont
• Investigators: Principal Investigator: Chris E Holmes, MD, PhD, University of Vermont and Fletcher Allen Health Care

Publications and helpful links

General Publications

• 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.

Helpful Links

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Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: March 4, 2008
• First Submitted That Met QC Criteria: March 11, 2008
• First Posted (Estimate): March 12, 2008

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Venous thrombosis; Edema; Post thrombotic syndrome; Thrombosis; Deep vein thrombosis; stasis ulcers
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Syndrome; Postthrombotic Syndrome; Postphlebitic Syndrome
• Other Study ID Numbers: CHRMS 08-065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No