Healthy AdultsNCT03461549
Pressure and Temperature Sensor for Therapeutic Compression Garments
An observational study of Healthy Adults and Venous Leg Ulcer, run by Northwestern University at 1 site in United States.
Trial summary
Pilot study of a soft, flexible pressure and temperature sensor Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults, Venous Leg Ulcer
- What is being tested?
- Pressure and Temperature Sensor
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2018to 10 Aug 2021
- Phase
- Observational
- 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
Study population: Healthy adults without a history of medical or surgical problem. There will be no subject compensation.
Who may be able to join
- Healthy adults over the age of 18 years old
Who cannot join
- Subjects with history of medical or surgical problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Preliminary Assessment of a Thin Flexible Pressure and Temperature Sensor for Therapeutic Compression Garments Using a Cohort of Healthy Adults Phase 2: Point-of-Care Wearable Pressure/Temp Sensor System for Therapeutic Compression Garments in Venous Leg Ulcers
Pilot study of a soft, flexible pressure and temperature sensor
Read the detailed description
Assessment of safety, and preliminary accuracy of a pressure and temperature sensor adherent to the skin. The pressure sensor includes a piezoresistive fabric coupled to a near-field communication chip with a built-in temperature sensor.
- Conditions
- Healthy Adults, Venous Leg Ulcer
- Being tested
- Pressure and Temperature Sensor
- Keywords
- pressure sensor, temperature sensor, wearables
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure and Temperature SensorDevice
This device includes pressure and temperature sensor embedded within silicone and applied to the skin with a medical grade adhesive.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Evaluate sensor performance on both lower limbs of healthy adult subjects for pressure sensing and skin temperature sensing. Receives: Device: Pressure and Temperature Sensor | |
| Venous Leg Ulcer Adults | Evaluate sensor performance on both lower limbs of adult subjects with an active venous leg ulcer or history of a venous leg ulcer for pressure sensing and skin temperature sensing. Receives: Device: Pressure and Temperature Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure comparison with PicoPress
Percent variation for each subject for pressure
Measured: 72 hours
Temperature with a comparator device (infrared camera)
Percent variation for each subject for temperature
Measured: 72 hours
Secondary outcomes (2)
Visual analogue scale of skin irritation
A minimum score is 0 and a maximum score is 100 with a range of 0-100. A score of 0 is defined as no visible clinical appreciation. A score of 100 is defined as severe skin irritation. Higher values indicate worse outcome. There are no subscales.
Measured: 72 hours
Participant survey
Survey regarding the comfort of the sensor
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start27 Feb 2018
- Primary completion8 Jul 2020
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Wearifi, Inc.
- Responsible party
- Principal investigator, Shuai (Steve) Xu, Northwestern University
- Investigators
- Shuai Xu, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461549
- Sponsor's protocol ID
- 090717SX
- Status last verified
- Jun 2022
- First submitted
- 28 Feb 2018
- Last updated
- 9 Jun 2022
- 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 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Preliminary Assessment of a Thin Flexible Pressure and Temperature Sensor for Therapeutic Compression Garments Using a Cohort of Healthy Adults Phase 2: Point-of-Care Wearable Pressure/Temp Sensor System for Therapeutic Compression Garments in Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT03461549
- Acronym / sponsor ID
- 090717SX
- Conditions
- Healthy Adults, Venous Leg Ulcer
- Keywords
- pressure sensor, temperature sensor, wearables
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Wearifi, Inc.
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 12 Mar 2018 (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.
Pilot study of a soft, flexible pressure and temperature sensor
Detailed description
Assessment of safety, and preliminary accuracy of a pressure and temperature sensor adherent to the skin. The pressure sensor includes a piezoresistive fabric coupled to a near-field communication chip with a built-in temperature sensor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Device: Pressure and Temperature SensorEvaluate sensor performance on both lower limbs of healthy adult subjects for pressure sensing and skin temperature sensing. |
| Venous Leg Ulcer Adults | – | Device: Pressure and Temperature SensorEvaluate sensor performance on both lower limbs of adult subjects with an active venous leg ulcer or history of a venous leg ulcer for pressure sensing and skin temperature sensing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults without a history of medical or surgical problem. There will be no subject compensation.
Key inclusion criteria (1 listed)
- Healthy adults over the age of 18 years old
Key exclusion criteria (1 listed)
- Subjects with history of medical or surgical problems
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 |
|---|---|---|
| Pressure and Temperature SensorThis device includes pressure and temperature sensor embedded within silicone and applied to the skin with a medical grade adhesive. | Device | Healthy adults, Venous Leg Ulcer Adults |
Primary outcome
Pressure comparison with PicoPress
Time frame: 72 hours
Percent variation for each subject for pressure
Temperature with a comparator device (infrared camera)
Time frame: 72 hours
Percent variation for each subject for temperature
2 secondary outcomes
Visual analogue scale of skin irritation
Time frame: 72 hours
Participant survey
Time frame: 15 minutes
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 9 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy Adults
Not yet recruitingPhase 1
A Study of Safety of SUN-0864 and How it is Processed by and Affects the Body in Healthy Adults and Healthy Adults Who Are Overweight or Obese.
Healthy Participants
Not yet recruiting
ACUTE EFFECTS OF HIGH-INTENSITY LASER THERAPY ON PAIN, MUSCLE STIFFNESS, AND GRIP STRENGTH IN HEALTHY ADULTS
Exercise-Induced Muscle Fatigue, Fatigue Recovery
RecruitingPhase 1
A Single Ascending Dose, and Food Effect Study of ABBV-7828 in Healthy Adults
Healthy Subjects
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
RecruitingObservational study
Fungal Infection Susceptibility
Cryptococcal Infection, Cryptococcal Pneumonia
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.
Shuai Xu principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adults and Venous Leg Ulcer, run by Northwestern University at 1 site in United States.
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 1 inclusion and 1 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 9 Jun 2022. 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 United States. 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?
Pressure comparison with PicoPress (time frame: 72 hours). The study lists 2 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 9 Jun 2022.