To evaluate the Koya wearable device - a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD)
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
121
Cross over after three month of use and a month of washout period
Stanley G Rockson
Oakland, California, United States
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 lowerr extremities. Volume is calculated based on cylindrical segment analysis. The outcome measure is assessed as a difference or change from baseline to month 3
Time frame: 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
Time frame: 3 months
Therapy adherence tracking
A table will be provided to patient to document days of use with the device to track adherence
Time frame: 3 months
Safety/AEs
As assessed by reported adverse events
Time frame: 3 months
Patient survey on preference
A study survey administered at the end of the study to measure patient preference between the two devices
Time frame: 3 months
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