New wearable device could ease leg swelling without bulky pumps
NCT ID NCT05507346
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a new portable, non-pneumatic compression device (Dayspring) against a standard pneumatic compression device for treating leg lymphedema. 121 adults with leg swelling used each device for three months, with a month off in between. Researchers measured changes in limb volume, quality of life, and how often people used the device.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- non-pneumatic active compression device (Dayspring)
- What this could lead to
- If successful, this could offer a more convenient, portable option for managing leg swelling from lymphedema or chronic venous insufficiency.
- What could go wrong
- This is a completed crossover study with 121 participants, so results are available but not yet widely published. The device may not work for everyone, and individual results vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
121 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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Jan 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 100 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Stanley G Rockson
Oakland, California, 94607, United States
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