Preliminary Investigation of a Smart Compression Therapy Prototype

NCT05610241 | Completed

• 1 other identifier: CI52248
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Compression Therapy; Two Layer Compression Wrap

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

Compression Therapy System Prototype

EXPERIMENTAL

Identifies legs randomized to receive the experimental intervention

Device: Compression Therapy System Prototype

Coban 2 (2 Layer Compression Wrap)

ACTIVE COMPARATOR

Identifies the legs randomized to receive the control intervention

Device: Standard Compression

Interventions

Compression Therapy System Prototype DEVICE

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.

Compression Therapy System Prototype

Standard Compression DEVICE

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.

Also known as: 2 Layer Compression Wrap, 2 Layer Compression Bandage, Coban 2

Coban 2 (2 Layer Compression Wrap)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DeRoyal Industries, Inc.: lead
• Royal College of Surgeons, Ireland: collaborator
• Tyndall National Institute: collaborator
• Enterprise Ireland: collaborator

Study Sites (1)

RCSI Education and Research Centre

Dublin, YN77, Ireland

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Declan Patton, PhD

  RCSI University of Medicine and Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The clinical research nurse applying the compression interventions will be blinded from interface pressure measurements
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Healthy volunteer study where participants serve as their own control, the control condition will be assigned to one leg and the experimental condition applied to the other leg.

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 9, 2022
• Study Start: March 4, 2023
• Primary Completion: March 18, 2023
• Study Completion: March 21, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)