Study to Evaluate the Safety and Effectiveness of Dayspring for Lower Extremity Lymphedema

Exclusion Criteria

• •Individuals with a history or presence of an acute systemic disorder or condition that could place the patient at increased risk from sequential compression therapy
• •Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
• •Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
• •Patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
• •Diagnosis of lipedema
• •Diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer)
• •Diagnosis of Acute infection (in the last four weeks)
• •Diagnosis of acute thrombophlebitis (in last 6 months)
• •Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
• •Diagnosis of pulmonary edema
• •Diagnosis of congestive heart failure (uncontrolled)
• •Diagnosis of chronic kidney disease with acute renal failure
• •Diagnosis of epilepsy
• •Patients with poorly controlled asthma
• •Any condition where increased venous and lymphatic return is undesirable
• •Women who are pregnant, planning a pregnancy or nursing at study entry
• •Participation in any clinical trial of an investigational substance or device during the past 30 days