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

This study has been terminated.
(Funding not available to continue with study.)
Sponsor:
Collaborator:
NormaTec Industries LP
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00951067
First received: August 3, 2009
Last updated: July 27, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention
Lymphedema
 Other: Exercise, Elevation, and Compression Garment
Device: E0650 PCD with non-sequential waveform
Device: E0651 PCD with sequential, non-gradient waveform
Device: E0652 PCD with sequential, gradient waveform
Device: E0652 PCD with peristaltic pulse waveform

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: August 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: NormaTec brand

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00951067

Locations
United States, Massachusetts
Children's Hospital Boston at Waltham
Waltham, Massachusetts, United States, 02453
Sponsors and Collaborators
Children's Hospital Boston
NormaTec Industries LP
Investigators
Principal Investigator: Arin K Greene, MD, MMSc Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Arin Greene, MD, Children's Hospital Boston, Plastic and Reconstructive Surgery
ClinicalTrials.gov Identifier: NCT00951067     History of Changes
Other Study ID Numbers: AQ-UE-LYMPHEDMA-PCD-RCT
Study First Received: August 3, 2009
Last Updated: July 27, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Lymphedema
Breast Cancer
Upper Extremity
Arm

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013