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Compression Device

Portable Compression Device for Lymphedema (GRANDE Trial)

N/A

Recruiting

Research Sponsored by Koya Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial will study a new portable device for treating lymphedema and phlebolymphedema to see how well it works and if it is cost-effective."

Who is the study for?

This trial is for individuals with conditions like lymphedema or chronic venous insufficiency, which cause swelling due to fluid buildup. Participants should be interested in trying a new portable device designed to help manage their condition.

What is being tested?

The study is testing the effectiveness and cost-efficiency of a new device called Dayspring. It's an active compression system that patients can use to potentially reduce swelling associated with lymphedema/phlebolymphedema.

What are the potential side effects?

Since the information provided does not specify side effects, it's assumed that potential risks may include discomfort from using the device, skin irritation, or possible worsening of symptoms if not used correctly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have swelling in my legs due to poor blood flow or lymph issues.

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I've been cleared of having deep vein thrombosis or vein issues after a specific vein test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot walk by myself.

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My BMI is over 34.

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I have been diagnosed with fluid in my lungs.

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I have been diagnosed with lipedema.

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I have an active wound or ulcer.

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I was diagnosed with acute thrombophlebitis in the last 2 months.

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I was diagnosed with a blood clot in my lungs or veins in the last 6 months.

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I have chronic kidney disease and recently developed acute renal failure.

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I am not pregnant, planning to become pregnant, or nursing.

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I am willing and able to follow the study rules and give informed consent.

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My cancer is active or has come back within the last 3 months.

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I have been diagnosed with epilepsy.

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I have been diagnosed with uncontrolled heart failure.

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My asthma is not well-managed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Lymphedema Overall Quality of Life and Patient Survey

Mobility (daily steps using a pedometer)

Secondary study objectives

LE Functional Index (LEFI)

Lower extremity edema response (limb girth reduction)

Safety/Adverse Events

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dayspring, Non-Pneumatic Active Compression Device (NPCD)Experimental Treatment1 Intervention

The Dayspring, an Non-Pneumatic Active Compression Device (NPCD) Active Wearable Compression Device is an FDA cleared calibrated active gradient pressure compression garment that is segmental and programmable and applies controlled sequential pressure from the distal to proximal-end of the limb in a cyclic manner.

0 / 16Eligibility criteria met