Treatment Trial for Post-Thrombotic Syndrome

NCT00633971 | Completed

• 1 other identifier: CHRMS 08-065
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Thrombotic Syndrome

Keywords

Post thrombotic syndrome; Thrombosis; Deep vein thrombosis; Venous thrombosis; Edema; stasis ulcers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

A

EXPERIMENTAL

Complex lymphedema therapy (which includes compression stocking use)

Other: complex lymphedema therapy

B

OTHER

Standard of care (compression stocking use at 30-40 mm Hg)

Other: complex lymphedema therapy

Interventions

complex lymphedema therapy OTHER

Patients with established post thrombotic syndrome will be randomized to either compression stocking use or complex lymphedema therapy.

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years.
• Diagnosis of post thrombotic syndrome.
• Median life expectancy of greater than 2 years.
• Previous history of lower extremity deep venous thrombosis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

Fletcher Allen Health Care; Department of Hematology/Oncology

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

• 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.

  PMID: 24558028 DERIVED

Related Links

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MeSH Terms

Conditions

Postthrombotic Syndrome; Thrombosis; Venous Thrombosis; Edema; Varicose Ulcer

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicose Veins; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chris E Holmes, MD, PhD

  University of Vermont and Fletcher Allen Health Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2011
• Last Updated: September 17, 2020

Record last verified: 2020-09

Locations

US (1)