An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
NPCD
Glenn Jacobowitz
New York, New York, United States
RECRUITINGLymphedema Overall Quality of Life and Patient Survey
The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, is also administered at baseline and month 3. Overall QoL is scored on a single item by the patient on a scale of 1-10. The outcome measure is assessed as a difference or change from baseline LYMQOL at day zero and month 6
Time frame: 6 months
Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)
Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)
Time frame: 6 months
Mobility (daily steps using a pedometer)
Mobility (daily steps using a pedometer)
Time frame: 6 months
Lower extremity edema response (limb girth reduction)
Lower extremity edema response (limb girth reduction)
Time frame: 6 months
LE Functional Index (LEFI)
LE Functional Index (LEFI)
Time frame: 6 months
Venous Clinical Severity Score (VCSS)
Venous Clinical Severity Score (VCSS) scored on severity from None (0), Mild (1), Moderate (2) to Severe (3). Higher score means a worse outcome
Time frame: 6 months
Safety/Adverse Events
As assessed by reported adverse events
Time frame: 6 months
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