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

This study has been withdrawn prior to enrollment.
(Funding not available to continue with study.)
Sponsor:
Collaborator:
NormaTec Industries LP
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00951067
First received: August 3, 2009
Last updated: January 30, 2014
Last verified: January 2014

August 3, 2009
January 30, 2014
August 2009
February 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00951067 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Lymphedema
  • Other: Exercise, Elevation, and Compression Garment

    Patients will be asked to daily:

    • exercise
    • elevate arm
    • wear an arm compression garment
  • 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
  • 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
  • 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
  • Device: E0652 PCD with peristaltic pulse waveform
    Use the E0652 PCD with peristaltic pulse waveform for two hours every day.
    Other Name: NormaTec brand
  • Active Comparator: Group A
    Exercise, Elevation, and Garment Compression
    Intervention: Other: Exercise, Elevation, and Compression Garment
  • Active Comparator: Group B
    Pneumatic Compression Device (B)
    Intervention: Device: E0650 PCD with non-sequential waveform
  • Active Comparator: Group C
    Pneumatic Compression Device (C)
    Intervention: Device: E0651 PCD with sequential, non-gradient waveform
  • Active Comparator: Group D
    Pneumatic Compression Device (D)
    Intervention: Device: E0652 PCD with sequential, gradient waveform
  • Active Comparator: Group E
    Pneumatic Compression Device (E)
    Intervention: Device: E0652 PCD with peristaltic pulse waveform
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00951067
AQ-UE-LYMPHEDMA-PCD-RCT
No
Children's Hospital Boston
Children's Hospital Boston
NormaTec Industries LP
Principal Investigator: Arin K Greene, MD, MMSc Children's Hospital Boston
Children's Hospital Boston
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP