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
Males and females ≥ 18 years of age
Capable and willing to sign the informed consent and deemed capable of following the study protocol
Subjects must have a diagnosis of unilateral or bilateral lower extremity edema or lower extremity lymphedema/phlebolymphedema as a consequence of chronic venous insufficiency
Subjects who have medical clearance using diagnostic confirmation through venous duplex to rule out DVT and superficial/deep reflux
Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy
Subjects must not have any diagnosed cognitive or physical impairment that would interfere with the use of the device
Non-ambulatory individuals
Single group
Dayspring
DeviceNPCD
Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)
Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)
Mobility (daily steps using a pedometer)
Mobility (daily steps using a pedometer)
Venous Clinical Severity Score (VCSS)
Venous Clinical Severity Score (VCSS)
Lower extremity edema response (limb girth reduction)
Lower extremity edema response (limb girth reduction)
Safety/Adverse Events
As assessed by reported adverse events
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