Chronic Venous Insufficiency, Lymphedema, Lymphedema, Lower Limb, Lymphedema of Leg, Venous Insufficiency
Conditions
Brief summary
To evaluate the Koya wearable device - a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD)
Detailed description
A Multi-center Randomized Control Single Cross-over Study to Evaluate the Safety and Effectiveness of Dayspring, a Novel Portable Non-Pneumatic Active Compression Device (NPCD) vs. an Advanced Pneumatic Compression Device (APCD) for Treating Lower Extremity Lymphedema. To evaluate the Dayspring, a Novel Portable Non-Pneumatic Active Compression Device (NPCD) in contrast to an advanced pneumatic compression device (APCD) in a multi-centered setting to evaluate volume, quality of life, safety, adherence, and preference.
Interventions
DEVICECross over Device (PCD or Dayspring - alternate to first group)
Cross over after three month of use and a month of washout period
Sponsors
Koya Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limb volume reduction or maintenance | 3 months | Limb volume measurement is performed by using a calibrated tape measure to measure circumference from the ankle at 4cm increments to the waist region. Measurements to be taken for both lowerr extremities. Volume is calculated based on cylindrical segment analysis. The outcome measure is assessed as a difference or change from baseline to month 3 |
| LYMQOL | 3 months | The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, is also administered at baseline and 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 |
| Therapy adherence tracking | 3 months | A table will be provided to patient to document days of use with the device to track adherence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety/AEs | 3 months | As assessed by reported adverse events |
| Patient survey on preference | 3 months | A study survey administered at the end of the study to measure patient preference between the two devices |
Countries
United States
Outcome results
None listed