Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema (PCD-LYMPH)

Boston Children's Hospital

Status: Withdrawn

Conditions: Lymphedema

Treatments: Device: E0650 PCD with non-sequential waveform; Device: E0652 PCD with sequential, gradient waveform; Device: E0652 PCD with peristaltic pulse waveform; Other: Exercise, Elevation, and Compression Garment; Device: E0651 PCD with sequential, non-gradient waveform

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00951067

AQ-UE-LYMPHEDMA-PCD-RCT

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 5 patient groups

Group A

Active Comparator group

Description:

Exercise, Elevation, and Garment Compression

Treatment:

Other: Exercise, Elevation, and Compression Garment

Group B

Active Comparator group

Description:

Pneumatic Compression Device (B)

Treatment:

Device: E0650 PCD with non-sequential waveform

Group C

Active Comparator group

Description:

Pneumatic Compression Device (C)

Treatment:

Device: E0651 PCD with sequential, non-gradient waveform

Group D

Active Comparator group

Description:

Pneumatic Compression Device (D)

Treatment:

Device: E0652 PCD with sequential, gradient waveform

Group E

Active Comparator group

Description:

Pneumatic Compression Device (E)

Treatment:

Device: E0652 PCD with peristaltic pulse waveform