About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dayspring