Chronic Venous Insufficiency, Lymphedema, Phlebolymphedema
Conditions
Brief summary
An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
Detailed description
An open-label, multi-center, prospective VA study to evaluate the effectiveness and health economics of a Novel Portable Non-Pneumatic Active Compression Device (NPCD) for lymphedema/phlebolymphedema
Interventions
DEVICEDayspring
NPCD
Sponsors
Koya Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower extremity edema response (limb girth reduction) | 6 months | Lower extremity edema response (limb girth reduction) |
| Safety/Adverse Events | 6 months | As assessed by reported adverse events |
Countries
United States
Outcome results
None listed