Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT00951067
Status:
WITHDRAWN
Last Update Posted:
2014-01-31
First Post:
2009-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema
Sponsor:
Boston Children's Hospital
Organization:
Study Overview
Official Title:
Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema
Status:
WITHDRAWN
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding not available to continue with study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PCD-LYMPH
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: