NCT00951067

Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema

Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Lymphedema

Interventions

Type	Name	Description
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.
DEVICE	E0651 PCD with sequential, non-gradient waveform	Use of an E0651 PCD with sequential, non-gradient waveform for two hours every day
DEVICE	E0652 PCD with sequential, gradient waveform	Use of an E0652 PCD with sequential, gradient waveform for two hours every day.
DEVICE	E0652 PCD with peristaltic pulse waveform	Use the E0652 PCD with peristaltic pulse waveform for two hours every day.

Timeline

• Start date: 2009-08-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2009-08-04
• Last updated: 2014-01-31

Locations

1 site across 1 country: United States