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Study of Dayspring for Lymphedema/Phlebolymphedema

This study is looking at a new portable compression device called Dayspring for people with lymphedema or phlebolymphedema (swelling caused by problems with your veins and lymphatic system). The researchers want to see how well Dayspring works and if it can save healthcare costs compared to usual care. They will measure things like your daily steps and a score for your vein health (Venous Clinical Severity Score or VCSS) over 6 months. You might be able to join if you are 18 to 100 years old and have swelling in one or both of your legs due to chronic venous insufficiency. This study is currently unclear on its recruitment status.

Study design
This is an open-label, multi-center study, meaning both you and your doctors will know you are receiving the Dayspring device. It plans to enroll 100 participants.
What's involved
The study will evaluate your mobility and vein health over a period of 6 months.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed for 6 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06418282

Clinical Study to Evaluate the Effectiveness and Health Economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for Lymphedema/Phlebolymphedema

Recruiting
NAAges 18+InterventionalTreatment
Koya Medical, Inc.
~100 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Dayspring

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)
Measured over 6 months
+2 more outcomes measured

Conditions

Phlebolymphedema
Lymphedema
Chronic Venous Insufficiency

Explore related trials

Chronic venous insufficiencyLymphedemaPhlebolymphedema

Where it's being run

1 sites across 1 states
New York1

Who to contact

Glenn Jacobowitz, MD
[email protected]
415-851-0337
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 unilateral or bilateral lower extremity edema or lower extremity lymphedema/phlebolymphedema as a consequence of chronic venous insufficiency
Subjects who have medical clearance using diagnostic confirmation through venous duplex to rule out DVT and superficial/deep reflux

Exclusion

Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
Individuals with a history or presence of a systemic disorder or condition that could place the subject at increased risk from sequential compression therapy
Subjects must not have any diagnosed cognitive or physical impairment that would interfere with the use of the device
Non-ambulatory individuals
Female: BMI \> 34 (5'4", 200 lbs.)
Male: BMI \> 34 (5'9", 230 lbs.)
(Max circumference at patella 58 cm; Max circumference at gluteal fold 75 cm)
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 active/open wound/ulcer
Diagnosis of acute thrombophlebitis (in last 2 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

What this trial measures

  • Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)6 months

    Cost comparison between NPCD and historical reference (as reflected by hospital/resource utilization related to adverse events)

  • Mobility (daily steps using a pedometer)6 months

    Mobility (daily steps using a pedometer)

  • Venous Clinical Severity Score (VCSS)180 days

    Venous Clinical Severity Score (VCSS)