A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Dayspring Active Wearable Compression System
PT works
Los Altos, California, United States
Ginger-K Lymphedema & Cancer Center
Morgan Hill, California, United States
LYMQOL (LYMphedema Quality of Life) ***All Relevant Time Points Used in the Calculation in the Time Frame (e.g., Baseline and 3 Months).***
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. Higher value is better on the QoL outcome and is more favorable.
Time frame: 3 months
Change in Edema Volume
Change in edema volume is measured as the difference between the edema volume at 3 months and edema volume at baseline. Edema volume is the difference in volume between the affected and unaffected limb. 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. A greater change in edema volume between the two time points is better on reduction of limb volume/swelling.
Time frame: 3 months
Safety/AEs
As assessed by reported adverse events
Time frame: 3 months
Number of Patients Using the Device Every Day for at Least 45 Minutes
Outcome measure will be evaluated based on number of patients that have used the device for the recommended use of 45 minutes per day over the duration of 3 months.
Time frame: 3 months
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