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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Patients will be asked to daily: * exercise * elevate arm * wear an arm compression garment
Use of an E0650 PCD with non-sequential waveform for two hours every day.
Use of an E0651 PCD with sequential, non-gradient waveform for two hours every day
Children's Hospital Boston at Waltham
Waltham, Massachusetts, United States
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
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
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Use of an E0652 PCD with sequential, gradient waveform for two hours every day.
Use the E0652 PCD with peristaltic pulse waveform for two hours every day.