Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema (PCD-LYMPH)

January 30, 2014 updated by: Boston Children's Hospital

Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema

The purpose of this study is to determine how well different treatments for acquired lymphedema work.

The study will compare 5 different non-invasive treatments for acquired lymphedema of the arm to see which treats lymphedema best.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study will compare 5 non-invasive lymphedema treatments.

Patients will be assigned to either:

- A combination of arm exercises, arm elevation, and wearing of a compression garment every day

OR

- One of four possible pneumatic compression devices for just two hours every day.

Pneumatic compression devices are made up of an inflatable sleeve connected to a small controller unit that is plugged into the wall. They feel like having your blood pressure taken.

None of the treatments are experimental. None of the treatments are invasive. All the treatments are considered standard of care and are used in clinics throughout the United States. All of the treatments will be done at home.

The trial will last for 7 and 1/2 months and will require follow-up visits to monitor progress.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Waltham, Massachusetts, United States, 02453
        • Children's Hospital Boston at Waltham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Patients diagnosed with acquired lymphedema of the arm.

Exclusion Criteria:

  • Refusal of consent
  • Unlikely compliance with the research protocol
  • Acute upper extremity DVT

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Exercise, Elevation, and Garment Compression
Other: Exercise, Elevation, and Compression Garment

Patients will be asked to daily:

  • exercise
  • elevate arm
  • wear an arm compression garment
Active Comparator: Group B
Pneumatic Compression Device (B)
Device: E0650 PCD with non-sequential waveform
Use of an E0650 PCD with non-sequential waveform for two hours every day.
Other Names:
  • Brand: Huntleigh Flowtron Hydroven™ 3
Active Comparator: Group C
Pneumatic Compression Device (C)
Device: E0651 PCD with sequential, non-gradient waveform
Use of an E0651 PCD with sequential, non-gradient waveform for two hours every day
Other Names:
  • Brand: Petite Basic System (Model 701A) Lympha Press
Active Comparator: Group D
Pneumatic Compression Device (D)
Device: E0652 PCD with sequential, gradient waveform
Use of an E0652 PCD with sequential, gradient waveform for two hours every day.
Other Names:
  • Brand: Bio Compression Sequential Circulator 3008
Active Comparator: Group E
Pneumatic Compression Device (E)
Device: E0652 PCD with peristaltic pulse waveform
Use the E0652 PCD with peristaltic pulse waveform for two hours every day.
Other Names:
  • NormaTec brand

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Arm Volume
Time Frame: Arm volume will be measured at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
Arm volume will be measured at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts

Secondary Outcome Measures

Outcome Measure
Time Frame
Infection (cellulitis)
Time Frame: Presence of infection will be recorded at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
Presence of infection will be recorded at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
Quality of Life Survey
Time Frame: Survey will be given at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts
Survey will be given at 2 weeks before treatment starts, day treatment begins, and then 1 month, 3 months, 6 months, and 7 months after treatment starts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Collaborators

NormaTec Industries LP

Investigators

  • Principal Investigator: Arin K Greene, MD, MMSc, Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

February 1, 2014

Study Registration Dates

First Submitted

August 3, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (Estimate)

August 4, 2009

Study Record Updates

Last Update Posted (Estimate)

January 31, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AQ-UE-LYMPHEDMA-PCD-RCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe