Clinical trial NCT05610241: Preliminary Investigation of a Smart Compression Therapy Prototype
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Venous Insufficiency of Leg
Keywords: Compression Therapy
Two Layer Compression Wrap
Lead sponsor: DeRoyal Industries, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Royal College of Surgeons, Ireland
name: Tyndall National Institute
name: Enterprise Ireland
First posted: 2022-11-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Apply Intervention by clinician
timeFrame: Measured on Day 0
measure: Time to Apply compression therapy prototype by volunteer
timeFrame: Measured on Day 0
measure: Interface Pressure after Application of Intervention
timeFrame: Measured on Day 1
measure: Average Interface Pressure during Walking
timeFrame: Measured at 0 hours, 1 hour, and 4 hours on Day 1
measure: Average Interface Pressure during Calf Pumping
timeFrame: Measured at 0 hours, 1 hour, and 4 hours on Day 1
measure: Average Interface Pressure during Standing
timeFrame: Measured at 0 hours, 1 hour, and 4 hours on Day 1
measure: Average Interface Pressure while laying down
timeFrame: Measured at 0 hours, 1 hour, and 4 hours on Day 1
measure: Accuracy of Compression Therapy System Prototype compared to Interface Pressure
timeFrame: Measured between 0 and 4 hours on day 1
measure: Visual Analogue Sensory (Pain) Assessment
timeFrame: Measured on Day 1 at hour 4
measure: Visual Analogue Skin Redness Assessment
timeFrame: Measured on Day 1 at hour 4 for both interventions; Measured on Day 2 - 4 for Compression Therapy System Prototype
measure: Usability Assessment
timeFrame: Completed on Day 1 for both interventions and daily on Day 2, 3, and 4 for the compression therapy system prototype
measure: At home usability assessment
timeFrame: Day 2 and 3
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: RCSI Education and Research Centre
Study officials:
affiliation: RCSI University of Medicine and Health Sciences
name: Declan Patton, PhD
role: STUDY_DIRECTOR
References: