A Clinical Study to Evaluate the Effectiveness of a Novel Portable Non-Pneumatic Active Compression Device vs. an Advanced Pneumatic Compression Device for Treating Lower Extremity Lymphedema

Not Applicable

Completed

• Conditions: Lymphedema, Lower Limb; Chronic Venous Insufficiency; Venous Insufficiency; Lymphedema; Lymphedema of Leg
• Interventions: Device: Cross over Device (PCD or Dayspring - alternate to first group)

• Registration Number: NCT05507346
• Lead Sponsor: Koya Medical, Inc.

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.

Study Timeline

• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-16
• Study First Posted: 2022-08-19
• Study Start: 2022-09-06
• Primary Completion: 2024-01-09
• Study Completion: 2024-01-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-21
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dayspring, Non-Pneumatic Active Compression Device (NPCD)	Cross over Device (PCD or Dayspring - alternate to first group)	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.
Advanced Pneumatic Compression Device (APCD)	Cross over Device (PCD or Dayspring - alternate to first group)	A commercially available advanced pneumatic compression device that is FDA-cleared for the same indication for use as the Dayspring Wearable Compression Device.

Primary Outcome Measures

Name	Time	Method
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
Therapy adherence tracking	3 months	A table will be provided to patient to document days of use with the device to track adherence
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stanley G Rockson; 🇺🇸 Oakland, California, United States