Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema

Lymphedema Clinical Trial

— PCD-LYMPH  

Official title:

Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00951067
• Other study ID #: AQ-UE-LYMPHEDMA-PCD-RCT
• Status: Withdrawn
• Phase: N/A
• First received: August 3, 2009
• Last updated: January 30, 2014
• Start date: August 2009
• Est. completion date: February 2014

Study information

• Verified date: January 2014
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphedema

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital Boston at Waltham	Waltham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Boston	NormaTec Industries LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No