Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema
NCT ID: NCT00951067
Last Updated: 2014-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2009-08-31
2014-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study will compare 5 different non-invasive treatments for acquired lymphedema of the arm to see which treats lymphedema best.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Compact Pneumatic Compression Device for Patients With Lymphedema
NCT04226287
Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device (PCD)
NCT02661646
A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
NCT04797390
Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema
NCT03825263
A Preference Study of Two Pneumatic Compression Devices for Patients With Lower Limb Lymphedema
NCT05485454
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
Exercise, Elevation, and Garment Compression
Exercise, Elevation, and Compression Garment
Patients will be asked to daily:
* exercise
* elevate arm
* wear an arm compression garment
Group B
Pneumatic Compression Device (B)
E0650 PCD with non-sequential waveform
Use of an E0650 PCD with non-sequential waveform for two hours every day.
Group C
Pneumatic Compression Device (C)
E0651 PCD with sequential, non-gradient waveform
Use of an E0651 PCD with sequential, non-gradient waveform for two hours every day
Group D
Pneumatic Compression Device (D)
E0652 PCD with sequential, gradient waveform
Use of an E0652 PCD with sequential, gradient waveform for two hours every day.
Group E
Pneumatic Compression Device (E)
E0652 PCD with peristaltic pulse waveform
Use the E0652 PCD with peristaltic pulse waveform for two hours every day.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exercise, Elevation, and Compression Garment
Patients will be asked to daily:
* exercise
* elevate arm
* wear an arm compression garment
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Unlikely compliance with the research protocol
* Acute upper extremity DVT
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NormaTec Industries LP
INDUSTRY
Boston Children's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arin K Greene, MD, MMSc
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital Boston at Waltham
Waltham, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AQ-UE-LYMPHEDMA-PCD-RCT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.