Preliminary Investigation of a Smart Compression Therapy Prototype (PRESUF-VLU)

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

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.

Study Overview

• Status: Completed
• Conditions: Venous Leg Ulcer; Venous Insufficiency of Leg
• Intervention / Treatment: Device: Compression Therapy System Prototype; Device: Standard Compression

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, YN77
    • RCSI Education and Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Intact, healthy skin at the application site in both legs
• Calf circumferences to be within 30 - 50 cm between the medial and lateral head of the gastrocnemius
• Able to understand the Patient Information Leaflet
• Willing and able to give informed consent
• Able to wear, don and doff the compression device without external help
• Willing and able to follow the requirements of the clinical investigation plan
• Presence of pedal pulses identified by hand-held Doppler (8 MHz)
• Ankle Brachial Pressure Index between 0.9 and 1.4

Exclusion Criteria:

• History of signs of previous deep or superficial vein thrombosis/pulmonary embolism
• Peripheral artery disease ( or ABPI < 0.90 or > 1.4), critical limb ischemia, or arterial ulceration
• Varicose veins, varicose eczema, or venous ulceration
• Chronic lower limb swelling, edema, lymphedema, or lipoedema
• Recent surgery within the last three months (such as abdominal, gynecological, hip or knee replacement, or lower limb) that may affect the study in the opinion of the investigator
• Recent trauma to a lower limb within the last three months
• Chronic obesity (defined as BMI index >40 kg/m^2)
• Diabetes mellitus
• Pregnancy
• A pulse rate of fewer than 40 beats/minute
• A sitting systolic blood pressure of > 180 and < 100 mmHg and/or a sitting diastolic pressure of > 100 mmHg
• Any significant illness during the previous four (4) weeks
• Participation in any clinical study during the eight (8) weeks preceding the screening period
• Any evidence of edema or pain
• Skin diseases, including wounds on the feet or lower limbs
• Any history of heart, liver, kidney, or vascular diseases
• History of having been prescribed compression stockings for treatment of a medical condition
• Serious allergies
• Dermatitis with oozing or fragile skin
• Persons currently using NSAID, Diuretics, Vasodilators, and steriods
• Drivers and Driving Professionals

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Compression Therapy System Prototype; Identifies legs randomized to receive the experimental intervention	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.
Active Comparator: Coban 2 (2 Layer Compression Wrap); Identifies the legs randomized to receive the control intervention	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.; Other Names: 2 Layer Compression Wrap; 2 Layer Compression Bandage; Coban 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Apply Intervention by clinician	The time it takes a clinician to place the assigned intervention to each limb	Measured on Day 0
Time to Apply compression therapy prototype by volunteer	The time it takes the volunteer to place the assigned intervention to each limb	Measured on Day 0
Interface Pressure after Application of Intervention	Interface pressure measured by pressure sensor (Pico Press) following application by research clinician	Measured on Day 1
Average Interface Pressure during Walking	The participant walks on a treadmill for 10 minutes. A pressure sensor (Pico Press) continuously measures compression at the medial gastrocnemius head. The interface pressure measurements are averaged over ten minutes of data collection. The analysis compares changes in pressure over the three measurements for each intervention.	Measured at 0 hours, 1 hour, and 4 hours on Day 1
Average Interface Pressure during Calf Pumping	The participant pumps each calf independently for 30 seconds. A pressure sensor (Pico Press) continuously measures compression at the medial gastrocnemius head. The interface pressure measurements are averaged over 30 seconds of data collection. The analysis compares changes in pressure over the three measurements for each intervention.	Measured at 0 hours, 1 hour, and 4 hours on Day 1
Average Interface Pressure during Standing	The participant stands for 30 seconds. A pressure sensor (Pico Press) continuously measures compression at the medial gastrocnemius head. The interface pressure measurements are averaged over 30 seconds of data collection. The analysis compares changes in pressure over the three measurements for each intervention.	Measured at 0 hours, 1 hour, and 4 hours on Day 1
Average Interface Pressure while laying down	The participant lays down on the bed for 30 seconds. A pressure sensor (Pico Press) continuously measures compression at the medial gastrocnemius head. The interface pressure measurements are averaged over 30 seconds of data collection. The analysis compares changes in pressure over the three measurements for each intervention.	Measured at 0 hours, 1 hour, and 4 hours on Day 1
Accuracy of Compression Therapy System Prototype compared to Interface Pressure	During data collection on day 1, the pressure sensor (Pico Press) will continuously monitor compression level applied to the calf. Researchers willl compare the pressure applied from the device to the measured pressure at the calf.	Measured between 0 and 4 hours on day 1
Visual Analogue Sensory (Pain) Assessment	Pain assessment completed by a 0 to 10 visual analog scale where 0 represents no pain and 10 represents severe pain.	Measured on Day 1 at hour 4
Visual Analogue Skin Redness Assessment	Visual Analogue Scale between 0 (no redness) to 10 (severe redness)	Measured on Day 1 at hour 4 for both interventions; Measured on Day 2 - 4 for Compression Therapy System Prototype
Usability Assessment	Questionnaire that allows research participants to score each intervention on a 1 (Strongly disagree) to 5 (Strongly agree) scale for the following questions: The intervention stayed in place while you are wearing it. The appearance of the intervention is aesthetically appealing The dimensions of the intervention are appropriate The weight of the intervention is comfortable when wearing it Overall I was able to successfully use the compression therapy prototype The user manual is helpful for me in managing the compression therapy prototype The instructions in the user manual are understandable (compression therapy prototype only) Overall, the Compression Therapy System Prototype is user friendly Overall, I feel comfortable when I use the intervention Overall, I feel confident when I use the intervention Overall I feel there is no risk to me when I use the intervention	Completed on Day 1 for both interventions and daily on Day 2, 3, and 4 for the compression therapy system prototype
At home usability assessment	Questions will be asked to healthy volunteers during three day period at home. Volunteers rate their response on a scale from 1 (strongly disagree) to 5 (strongly agree). I learned to use the compression therapy prototype quickly I learned to use the compression therapy prototype easily I easily remember how to use the compression therapy prototype I quickly became skillful with the compression therapy prototype It isn't necessary to have too much previous knowledge to use the compression therapy prototype The instructions for use are clear and easy to understand The LED signs from the compression therapy prototype is accurate Overall, I was able to successfully interpret the LED signs of the compression therapy prototype The LED signs of the compression therapy prototype are understandable and easy to interpret The LED signs were helpful for me in managing the compression therapy prototype The LED signs allow me to correct mistakes quickly and easily	Day 2 and 3

Collaborators and Investigators

• Sponsor: DeRoyal Industries, Inc.
• Collaborators: Royal College of Surgeons, Ireland; Enterprise Ireland; Tyndall National Institute
• Investigators: Study Director: Declan Patton, PhD, RCSI University of Medicine and Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2023
• Primary Completion (Actual): March 18, 2023
• Study Completion (Actual): March 21, 2023

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Compression Therapy; Two Layer Compression Wrap
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Varicose Ulcer; Venous Insufficiency
• Other Study ID Numbers: CI52248

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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