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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00951067 |
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Date of registration:
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03/08/2009 |
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Primary sponsor: |
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Public title:
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Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema
PCD-LYMPH |
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Scientific title:
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Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema |
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Date of first enrolment:
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August 2009 |
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Target sample size:
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75 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00951067 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Arin K Greene, MD, MMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Boston |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lymphedema
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Intervention(s)
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Device: E0650 PCD with non-sequential waveform
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Device: E0651 PCD with sequential, non-gradient waveform
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Device: E0652 PCD with peristaltic pulse waveform
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Device: E0652 PCD with sequential, gradient waveform
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Other: Exercise, Elevation, and Compression Garment
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Primary Outcome(s)
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Arm Volume
[Time Frame: 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]
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Secondary Outcome(s)
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Infection (cellulitis)
[Time Frame: 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]
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Quality of Life Survey
[Time Frame: 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]
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Secondary ID(s)
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AQ-UE-LYMPHEDMA-PCD-RCT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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