NCT05610241

Preliminary Investigation of a Smart Compression Therapy Prototype

Preliminary Testing of the Safety, Usability and Functionality of an Innovative and Smart Medical Device: Compression Therapy System Prototype for Venous Leg Ulcer Treatment in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: DeRoyal Industries, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Compression wraps treat venous leg ulcers when applied correctly. Often, clinicians apply the wraps at the wrong compression, or the wrap loosens, stopping clinical benefits. The study aims to show the feasibility of a smart compression prototype to maintain a set compression level in healthy volunteers. Each volunteer will wear the prototype device on one leg and a standard compression wrap on the other. Volunteers will pump their calves, walk, lie down, and stand at zero, one, and four hours. A pressure sensor placed over each calf will record the compression level during the activities. Volunteers will provide subjective feedback on each device concerning comfort and usability. After four hours, researchers will remove the standard wrap. Volunteers will use the prototype device during daily activities for three days. During the three days, the volunteers will complete a daily journal. The journal will capture the user experience and time the volunteer used the device. A final site visit allows researchers to conduct exit interviews and download the history of applied compression. Researchers will use the data to show that the prototype device maintains therapeutic compression and prove the usability of the device.

Conditions

• Venous Leg Ulcer
• Venous Insufficiency of Leg

Interventions

Type	Name	Description
DEVICE	Compression Therapy System Prototype	A device designed to deliver compression therapy at a pre-set level to the lower leg for legs with a circumference between 30-50 cm. The device provides compression through a series of three air bladders and is controlled by a battery-powered electronic module that controls compression levels by monitoring bladder pressure.
DEVICE	Standard Compression	Coban 2 represents the standard of care 2-layer compression wrap used to treat venous leg ulcers. The device consists of a comfort layer and a compression layer. A clinician applies the device to establish compression therapy.

Timeline

• Start date: 2023-03-04
• Primary completion: 2023-03-18
• Completion: 2023-03-21
• First posted: 2022-11-09
• Last updated: 2023-09-07

Locations

1 site across 1 country: Ireland