Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema

Not Applicable

Withdrawn

• Conditions: Lymphedema
• Interventions: 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

• Registration Number: NCT00951067
• Lead Sponsor: Boston Children's Hospital

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 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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-04
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-30
• Last Update Posted: 2014-01-31
• Primary Completion: 2014-02
• Study Completion: 2014-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Exercise, Elevation, and Compression Garment	Exercise, Elevation, and Garment Compression
Group B	E0650 PCD with non-sequential waveform	Pneumatic Compression Device (B)
Group C	E0651 PCD with sequential, non-gradient waveform	Pneumatic Compression Device (C)
Group D	E0652 PCD with sequential, gradient waveform	Pneumatic Compression Device (D)
Group E	E0652 PCD with peristaltic pulse waveform	Pneumatic Compression Device (E)

Primary Outcome Measures

Name	Time	Method
Arm Volume	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

Secondary Outcome Measures

Name	Time	Method
Infection (cellulitis)	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	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

Trial Locations

Locations (1)

Children's Hospital Boston at Waltham; 🇺🇸 Waltham, Massachusetts, United States