Trial Outcomes & Findings for Study to Evaluate the Safety and Effectiveness of Dayspring for Lower Extremity Lymphedema (NCT NCT04897035)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

3 months

Results posted on

2026-02-17

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects With Lower Extremity Lymphedema and Phlebolymphedema Lower Extremity Lymphedema and phlebolymphedema Dayspring Active Wearable Compression System: Dayspring Active Wearable Compression System
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With Lower Extremity Lymphedema and Phlebolymphedema n=24 Participants Lower Extremity Lymphedema and phlebolymphedema Dayspring Active Wearable Compression System: Dayspring Active Wearable Compression System
Age, Continuous	63 years STANDARD_DEVIATION 14 • n=25 Participants
Sex: Female, Male Female	17 Participants n=25 Participants
Sex: Female, Male Male	7 Participants n=25 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants
Race (NIH/OMB) Asian	0 Participants n=25 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants
Race (NIH/OMB) Black or African American	2 Participants n=25 Participants
Race (NIH/OMB) White	22 Participants n=25 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Higher value is better on the QoL outcome and is more favorable. The difference greater than 0 between baseline and end of study is more favorable

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.

Outcome measures

Outcome measures
Measure	Subjects With Lower Extremity Lymphedema and Phlebolymphedema n=24 Participants Lower Extremity Lymphedema and phlebolymphedema Dayspring Active Wearable Compression System: Dayspring Active Wearable Compression System
LYMQOL (LYMphedema Quality of Life) *All Relevant Time Points Used in the Calculation in the Time Frame (e.g., Baseline and 3 Months).*	.83 units on a scale Standard Error .02

PRIMARY outcome

Timeframe: 3 months

Population: Higher value is better on reduction of limb volume/swelling.

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.

Outcome measures

Outcome measures
Measure	Subjects With Lower Extremity Lymphedema and Phlebolymphedema n=24 Participants Lower Extremity Lymphedema and phlebolymphedema Dayspring Active Wearable Compression System: Dayspring Active Wearable Compression System
Change in Edema Volume	427.1 Mean change in edema volu,e, cm3 Standard Deviation 56

SECONDARY outcome

Timeframe: 3 months

As assessed by reported adverse events

Outcome measures

Outcome measures
Measure	Subjects With Lower Extremity Lymphedema and Phlebolymphedema n=24 Participants Lower Extremity Lymphedema and phlebolymphedema Dayspring Active Wearable Compression System: Dayspring Active Wearable Compression System
Safety/AEs	0 Participants

SECONDARY outcome

Timeframe: 3 months

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.

Outcome measures

Outcome measures
Measure	Subjects With Lower Extremity Lymphedema and Phlebolymphedema n=24 Participants Lower Extremity Lymphedema and phlebolymphedema Dayspring Active Wearable Compression System: Dayspring Active Wearable Compression System
Number of Patients Using the Device Every Day for at Least 45 Minutes	24 Patients using device every day

Adverse Events

Subjects With Lower Extremity Lymphedema and Phlebolymphedema

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Affairs

Koya Medical

Phone: 4158510337

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place