A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema

Study Overview
=================
Brief Summary
-----------------
To evaluate the Koya wearable device - a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD)

Detailed Description
-----------------
A Multi-center Randomized Control Single Cross-over Study to Evaluate the Safety and Effectiveness of Dayspring, a Novel Portable Non-Pneumatic Active Compression Device (NPCD) vs. an Advanced Pneumatic Compression Device (APCD) for Treating Lower Extremity Lymphedema. To evaluate the Dayspring, a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD) in a multi-centered setting to evaluate volume, quality of life, safety, adherence, and preference.

Official Title
-----------------
A Multi-center Randomized Control Cross-over Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema (TEAYS)

Conditions
-----------------
Lymphedema, Lymphedema of Leg, Chronic Venous Insufficiency, Venous Insufficiency, Lymphedema, Lower Limb

Intervention / Treatment
-----------------
* Device: Cross over Device (PCD or Dayspring - alternate to first group)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 primary or secondary unilateral or bilateral lower extremity edema or lower extremity phlebolymphedema from chronic venous insufficiency Subjects who have medical clearance for the safe application of limb compression, using diagnostic confirmation of a complete arterial Doppler study and/or Ankle-brachial Index (ABI) screening Exclusion Criteria: Individuals with a history or presence of a systemic disorder or condition that could place the subject 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 Subjects with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.) Subjects must not have any diagnosed cognitive or physical impairment that would interfere with use of the device Individuals who present with Ankle-brachial Index (ABI) screening score < 0.8 and > 1.30, indicating the possibility of Peripheral Arterial disease (PAD) 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/uncompensated) Diagnosis of chronic kidney disease with acute renal failure Diagnosis of epilepsy Subjects 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
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dayspring, Non-Pneumatic Active Compression Device (NPCD)<br>The Dayspring, an Non-Pneumatic Active Compression Device (NPCD) Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure compression garment that is segmental and programmable and applies controlled sequential pressure from the distal to proximal-end of the limb in a cyclic manner. | Device: Cross over Device (PCD or Dayspring - alternate to first group)<br>* Cross over after three month of use and a month of washout period<br>|
| Active Comparator: Advanced Pneumatic Compression Device (APCD)<br>A commercially available advanced pneumatic compression device that is FDA-cleared for the same indication for use as the Dayspring Wearable Compression Device. | Device: Cross over Device (PCD or Dayspring - alternate to first group)<br>* Cross over after three month of use and a month of washout period<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limb volume reduction or maintenance | Limb volume measurement is performed by using a calibrated tape measure to measure circumference from the ankle at 4cm increments to the waist region. Measurements to be taken for both upper extremities. Volume is calculated based on cylindrical segment analysis. The outcome measure is assessed as a difference or change from baseline to month 3 | 3 months | 
| LYMQOL | 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 3 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/AEs | As assessed by reported adverse events | 3 months | 
| Therapy adherence tracking | A table will be provided to patient to document days of use with the device to track adherence | 3 months | 
| Patient survey on preference | A study survey administered at the end of the study to measure patient preference between the two devices | 3 months |