Treatment Trial for Post-Thrombotic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post Thrombotic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A

Complex lymphedema therapy (which includes compression stocking use)

Group Type EXPERIMENTAL

complex lymphedema therapy

Intervention Type OTHER

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

B

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

Group Type OTHER

complex lymphedema therapy

Intervention Type OTHER

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

Interventions

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complex lymphedema therapy

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No