Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lymphedema

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Exercise, Elevation, and Garment Compression | Other: Exercise, Elevation, and Compression Garment<br>* Patients will be asked to daily: exercise elevate arm wear an arm compression garment<br>|
| Active Comparator: Group B<br>Pneumatic Compression Device (B) | Device: E0650 PCD with non-sequential waveform<br>* Use of an E0650 PCD with non-sequential waveform for two hours every day.<br>* Other names: Brand: Huntleigh Flowtron Hydroven™ 3;|
| Active Comparator: Group C<br>Pneumatic Compression Device (C) | Device: E0651 PCD with sequential, non-gradient waveform<br>* Use of an E0651 PCD with sequential, non-gradient waveform for two hours every day<br>* Other names: Brand: Petite Basic System (Model 701A) Lympha Press;|
| Active Comparator: Group D<br>Pneumatic Compression Device (D) | Device: E0652 PCD with sequential, gradient waveform<br>* Use of an E0652 PCD with sequential, gradient waveform for two hours every day.<br>* Other names: Brand: Bio Compression Sequential Circulator 3008;|
| Active Comparator: Group E<br>Pneumatic Compression Device (E) | Device: E0652 PCD with peristaltic pulse waveform<br>* Use the E0652 PCD with peristaltic pulse waveform for two hours every day.<br>* Other names: NormaTec brand;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphedema, Breast Cancer, Upper Extremity, Arm