A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

Study Overview
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Brief Summary
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A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

Detailed Description
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A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

Official Title
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A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

Conditions
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Lymphedema Lower Extremity, Lymphedema, Chronic Venous Insufficiency, Secondary Lymphedema

Intervention / Treatment
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* Device: Dayspring Active Wearable Compression System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females ≥ 18 years of age Willing to sign the informed consent and deemed capable of following the study protocol Subjects must have a diagnosis of primary or secondary unilateral lower extremity edema At the time of initial evaluation, individuals must be at least 3 months post surgery, chemotherapy and/or radiation treatment for cancer if applicable 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with Lower Extremity Lymphedema and phlebolymphedema<br>Lower Extremity Lymphedema and phlebolymphedema | Device: Dayspring Active Wearable Compression System<br>* Dayspring Active Wearable Compression System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LYMQOL (LYMphedema Quality of Life) | The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, was also administered at baseline and at 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 3. | 3 months | 
| Limb Volume Maintenance or Improvement | Limb volume measurement is performed by using a calibrated tape measure to measure circumference from the ankle and at 4cm increments to the waist region. Measurements are taken for both lower extremities. Volume is calculated based on cylindrical segment analysis. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/AEs | As assessed by reported adverse events | 3 months | 
| Therapy adherence tracking | Therapy adherence tracked via the mobile app that records usage per day. Outcome measure will be evaluated based on recommended use of 45 minutes per day over the duration of 3 months. | 3 months | 
| Patient survey | A visual analog scale (VAS) 1-5 and study survey were administered at the end of the study to measure patient satisfaction. The six-item questionnaire was used to document the time of day the device was used, if daily activities were supported during use, function, and symptoms. The VAS was administered to previous users of pneumatic compression devices to assess preference and likelihood to recommend to others with lymphedema. | 3 months |