Venous Leg UlcerPRESUF-VLUNCT05610241
Preliminary Investigation of a Smart Compression Therapy Prototype
A study testing Compression Therapy System Prototype and Standard Compression in people with Venous Leg Ulcer and Venous Insufficiency of Leg, run by DeRoyal Industries, Inc. at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Leg Ulcer, Venous Insufficiency of Leg
- What is being tested?
- Compression Therapy System Prototype and Standard Compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteIreland
- Study dates
- 4 Mar 2023to 21 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Compression Therapy System Prototype, Standard Compression
- Keywords
- Compression Therapy, Two Layer Compression Wrap
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression Therapy System PrototypeDevice
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.
Standard CompressionDevice
Also called 2 Layer Compression Wrap, 2 Layer Compression Bandage, Coban 2
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.
| Study group | Role | What they receive |
|---|---|---|
| Compression Therapy System Prototype | Experimental | Identifies legs randomized to receive the experimental intervention Receives: Device: Compression Therapy System Prototype |
| Coban 2 (2 Layer Compression Wrap) | Active comparator | Identifies the legs randomized to receive the control intervention Receives: Device: Standard Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Apply Intervention by clinician
The time it takes a clinician to place the assigned intervention to each limb
Measured: 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: Measured on Day 0
Interface Pressure after Application of Intervention
Interface pressure measured by pressure sensor (Pico Press) following application by research clinician
Measured: 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: 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: 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: 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: 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: 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: Measured on Day 1 at hour 4
Visual Analogue Skin Redness Assessment
Visual Analogue Scale between 0 (no redness) to 10 (severe redness)
Measured: 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
Measured: 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
Measured: Day 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start4 Mar 2023
- Primary completion18 Mar 2023
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Leg UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeRoyal Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal College of Surgeons, Ireland, Tyndall National Institute, Enterprise Ireland
- Responsible party
- Sponsor
- Investigators
- Declan Patton, PhD, Study director, RCSI University of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610241
- Sponsor's protocol ID
- CI52248
- Acronym
- PRESUF-VLU
- Status last verified
- Sep 2023
- First submitted
- 2 Nov 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05610241
- Acronym / sponsor ID
- PRESUF-VLU / CI52248
- Conditions
- Venous Leg Ulcer, Venous Insufficiency of Leg
- Keywords
- Compression Therapy, Two Layer Compression Wrap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- DeRoyal Industries, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Royal College of Surgeons, Ireland, Tyndall National Institute, Enterprise Ireland
- Study start
- 4 Mar 2023 (actual)
- Primary completion
- 18 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Compression Therapy System Prototype | Experimental | Device: Compression Therapy System PrototypeIdentifies legs randomized to receive the experimental intervention |
| Coban 2 (2 Layer Compression Wrap) | Active comparator | Device: Standard CompressionIdentifies the legs randomized to receive the control intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression Therapy System PrototypeA 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 | Compression Therapy System Prototype |
| Standard CompressionAlso: 2 Layer Compression Wrap, 2 Layer Compression Bandage, Coban 2Coban 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. | Device | Coban 2 (2 Layer Compression Wrap) |
Primary outcome
Time to Apply Intervention by clinician
Time frame: Measured on Day 0
The time it takes a clinician to place the assigned intervention to each limb
Time to Apply compression therapy prototype by volunteer
Time frame: Measured on Day 0
The time it takes the volunteer to place the assigned intervention to each limb
Interface Pressure after Application of Intervention
Time frame: Measured on Day 1
Interface pressure measured by pressure sensor (Pico Press) following application by research clinician
Average Interface Pressure during Walking
Time frame: Measured at 0 hours, 1 hour, and 4 hours on Day 1
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.
Average Interface Pressure during Calf Pumping
Time frame: Measured at 0 hours, 1 hour, and 4 hours on Day 1
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.
Average Interface Pressure during Standing
Time frame: Measured at 0 hours, 1 hour, and 4 hours on Day 1
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.
Average Interface Pressure while laying down
Time frame: Measured at 0 hours, 1 hour, and 4 hours on Day 1
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.
Accuracy of Compression Therapy System Prototype compared to Interface Pressure
Time frame: Measured between 0 and 4 hours on day 1
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.
Visual Analogue Sensory (Pain) Assessment
Time frame: Measured on Day 1 at hour 4
Pain assessment completed by a 0 to 10 visual analog scale where 0 represents no pain and 10 represents severe pain.
Visual Analogue Skin Redness Assessment
Time frame: Measured on Day 1 at hour 4 for both interventions; Measured on Day 2 - 4 for Compression Therapy System Prototype
Visual Analogue Scale between 0 (no redness) to 10 (severe redness)
Usability Assessment
Time frame: Completed on Day 1 for both interventions and daily on Day 2, 3, and 4 for the compression therapy system prototype
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
At home usability assessment
Time frame: Day 2 and 3
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Declan Patton, PhD study director
RCSI University of Medicine and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression Therapy System Prototype and Standard Compression in people with Venous Leg Ulcer and Venous Insufficiency of Leg, run by DeRoyal Industries, Inc. at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Apply Intervention by clinician (time frame: Measured on Day 0). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.