Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study (DAYSPRING)

An open-label study to clinically assess a novel wearable advanced compression technology (Dayspring™) undertaken to determine if potential barriers to lymphedema self-care were effectively addressed. The Dayspring™ device is a novel FDA-cleared wearable solution that is portable and easy-to-use sequential compression system. The following endpoints are examined:

1. Improvement in QoL in subject with upper-extremity edema after 28 days as measured by the LYMQOL disease-specific validated assessment tool.
2. Arm volume maintenance or improvement as measured prior to and after 28 days of device use.
3. Safety as assessed by reported adverse events
4. Patient satisfaction as measured by visual analog scale (VAS) and survey at the end of the study; and
5. Adherence to therapy as measured with a smart phone app.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Lymphedema; Lymphedema of Upper Arm; Breast Cancer Related Lymphedema
• Intervention / Treatment: Device: User of Dayspring device

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Altos, California, United States, 94024
      • PT works
    • Morgan Hill, California, United States, 95037
      • Ginger-K Lymphedema & Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females ≥ 18 years of age
• 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 upper extremity edema

Exclusion Criteria:

• Individuals with a history or presence of a systemic disorder or condition that could place the patient 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
• Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
• Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer
• Diagnosis of Acute infection (in the last two weeks)
• Diagnosis of acute thrombophlebitis (in last 2 months)
• Diagnosis of peripheral arterial disease (PAD): PAD is defined as an Ankle Brachial Index (ABI), of 0.7 or lower
• Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
• Diagnosis of pulmonary edema
• Diagnosis of congestive heart failure (uncontrolled)
• Diagnosis of chronic kidney disease
• Diagnosis of epilepsy
• Patients 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Breast-cancer related lymphedema (BCRL)	Device: User of Dayspring device; The Dayspring™ device is a novel FDA-cleared wearable solution that is portable and easy-to-use sequential compression system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LYMQOL (LYMphedema Quality of Life)	The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, was also administered at baseline and at day 28. Overall QoL is scored on a single item by the patient on a scale of 1-10.	28 days
Arm Volume Maintenance or Improvement	Limb volume measurement was performed by using a calibrated tape measure to measure circumference from the wrist and the ulnar styloid process and at 4cm increments to the axilla. Measurements were taken for both upper extremities. If both extremities exhibited edema, a study arm was designated for treatment. Measurements were taken by the same investigator throughout the study. Volume was calculated based on cylindrical segment analysis.	28 days
Safety/AEs	As assessed by reported adverse events	28 days
Therapy adherence tracking	Therapy adherence tracked via the mobile app linked to the Dayspring™ device.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient survey	A visual analog scale (VAS) and study survey were administered at the end of the study to measure patient satisfaction (day 28). The six-item questionnaire was used to document the time of day the device was used, if daily activities were supported during use, function, and symptoms. All were measured on a scale from 1-5. The VAS was administered to previous users of pneumatic compression devices to assess preference and likelihood to recommend to others with lymphedema.	28 days

Collaborators and Investigators

• Sponsor: Koya Medical, Inc.
• Investigators: Principal Investigator: Stanley G Rockson, MD, Medical Advisor

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2020
• Primary Completion (Actual): May 28, 2021
• Study Completion (Actual): May 28, 2021

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Lymphatic Diseases; Postoperative Complications; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: KCT001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No