Clinical Trial: Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Boston Children’s Hospital

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Boston Children’s Hospital

Dates:
Date Received: August 3, 2009
Date Started: August 2009
Date Completion: February 2014
Last Updated: January 30, 2014
Last Verified: January 2014