Skin PhysiologyProTexNCT04008160
Intelligent Underwear (IU) in Paraplegics
An observational study of Skin Physiology and Spinal Cord Injuries, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
Pressure injuries are a major problem in patients with no or limited mobility and sensation such as paraplegics. Changes in skin physiology like changes in skin perfusion, oxygenation and humidity may explain and help to detect pressure injury development earlier. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Physiology, Spinal Cord Injuries, Pressure Injury
- What is being tested?
- ProTex
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2022to 1 Jun 2023
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy volunteers and individuals with paraplegia
Who may be able to join
- men and women
- age: 18 - 50 years
Who cannot join
- Any sign of pressure ulcer or a history of pressure ulcer on the ischium
- Diabetes
- Acute infection or disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intelligent Underwear (IU) Monitors Pressure, Temperature, Perfusion, Humidity, and Oxygenation in Paraplegics
Pressure injuries are a major problem in patients with no or limited mobility and sensation such as paraplegics. Changes in skin physiology like changes in skin perfusion, oxygenation and humidity may explain and help to detect pressure injury development earlier. Thus, these parameters may be used for continuous monitoring of skin health. So far, there is no measuring technology available which would allow to measure continuously and quantitatively the physiological parameters, which are essential in the development of pressure injuries, over a long period of time in the clinical setting.
The goal of this pilot study is to test whether this wearable technology can be used for measurements of skin parameter and whether temperature, pressure, humidity, perfusion, and oxygenation can be measured safely and accurately.
10 healthy individuals and 10 individuals with spinal cord will be enrolled for measurements with this newly developed device over the ischium for 30 minutes. The reproducibility of the measurements will be investigated.
Read the detailed description
Background of the study:
Pressure injury is a major problem in patients with no or limited mobility and sensation such as paraplegics. One of the main principles to prevent development of pressure injury is to reduce the pressure over certain regions by changing the resting or lying position periodically. Paraplegics who are suffering from loss of sensation in some parts of the body are at high risk because of the missing internal trigger to change the position regularly. Many studies have addressed the personal, social, medical and economic consequences of pressure injuries. Some studies have investigated solutions aiming to reduce the probability of pressure injury development, such as special mattresses or the frequency of moving the patients from one side to the other etc. So far it has not yet been possible to quantitatively and continuously measure the physiological skin parameters, which are essential in the development of pressure injury, over a long period of time. Up to now, long-term studies on paraplegics are limited because there are no suitable measurement devices. Current measurement devices are hard and inflexible and increase the probability of pressure ulcer development in paraplegics by applying external pressure on the tissue. In this project, the applicability of wearable measuring systems, which do not apply external pressure on the tissue, will be evaluated in paraplegics.
Aim of the study:
The goal of the study is to answer the following questions:
- Is wearable technology usable for skin physiology measurements in paraplegics?
- Are the measurements of skin temperature, pressure, humidity, perfusion, and oxygenation reproducible in able bodied individuals?
- Do changes in skin temperature, pressure, humidity, perfusion, and oxygenation differ between paraplegics and healthy subjects?
Study design Two different measurement patches will be used. One patch consists of temperature, pressure, humidity and perfusion sensors. The second patch consists of near-infrared spectroscopy (NIRS) sensors (to measure oxygenation). This patch is designed for non-invasive measurement of oxygenation parameters such as oxygen saturation, oxygen consumption etc. The study is divided into two parts. The first part will be performed in 10 healthy subjects and 3 paraplegics. There will be two measurements in paraplegics and three measurements in healthy subjects, each for 10 minutes. The second part which will be conducted in 10-20 subjects (5-10 healthy and 5-10 paraplegics). The skin parameters will be measured for an hour.
Part 1a healthy subjects:
The subject will acclimatize in the room where the experiment takes place for 15 minutes. Then the patch will be placed over the ischium of the patient. Ischium will be localized manually and the patch will be placed in the underwear of the participant. The subject will be asked to sit for 10 minutes in a chair.
Part 1b paraplegics:
The subject will acclimatize in the room where the experiment takes place for 15 minutes. Then the patch will be placed over the ischium of the patient. Ischium will be localized manually and the patch will be placed in the underwear of the participant. The subject will be asked to sit for 10 minutes in a in a standard wheelchair.
Part 2:
The same procedure will be carried out with the only difference that the measurements will last 60 minutes.
Statistical Analyses:
Data will be analyzed descriptively. The reproducibility of the data will be analyzed using intraclass correlation coefficients (ICC).
The differences between data from paraplegics and that of healthy subjects will be analyzed using the Mann-Whitney-U-Test.
.
- Conditions
- Skin Physiology, Spinal Cord Injuries, Pressure Injury
- Being tested
- ProTex
- Keywords
- perfusion, oxygenation, non invasive measurement
- Medical subject headings
- Spinal Cord Injuries, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProTexDevice
Non invasive measurement of pressure, temperature, humidity, perfusion, and oxygenation
| Study group | Role | What they receive |
|---|---|---|
| healthy persons | Not described Receives: Device: ProTex | |
| individuals with paraplegia | Not described Receives: Device: ProTex |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of pressure on skin
measuring skin surface pressure with a pressure sensor in the underpants
Measured: baseline and 10 minutes later
Secondary outcomes (4)
change in skin temperature
measuring skin surface temperature with a thermometer sensor in the underpants
Measured: baseline and 10 minutes later
change in skin perfusion
measuring skin surface perfusion with a flow sensor in the underpants
Measured: baseline and 10 minutes later
change in skin humidity
measuring skin surface humidity with a hygrometer sensor in the underpants
Measured: baseline and 10 minutes later
change in skin oxygenation
measuring skin oxygenation with a near-infrared spectroscopy sensor in the underpants
Measured: baseline and 10 minutes later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Oct 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Why it stopped: responsible parties no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin PhysiologyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Collaborators
- University of Bern
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008160
- Sponsor's protocol ID
- 2013-04
- Acronym
- ProTex
- Status last verified
- May 2025
- First submitted
- 1 Jul 2019
- Last updated
- 28 May 2025
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Underwear (IU) Monitors Pressure, Temperature, Perfusion, Humidity, and Oxygenation in Paraplegics
- ClinicalTrials.gov ID
- NCT04008160
- Acronym / sponsor ID
- ProTex / 2013-04
- Conditions
- Skin Physiology, Spinal Cord Injuries, Pressure Injury
- Keywords
- perfusion, oxygenation, non invasive measurement
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: responsible parties no longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Collaborators
- University of Bern
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 5 Jul 2019 (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.
Pressure injuries are a major problem in patients with no or limited mobility and sensation such as paraplegics. Changes in skin physiology like changes in skin perfusion, oxygenation and humidity may explain and help to detect pressure injury development earlier. Thus, these parameters may be used for continuous monitoring of skin health. So far, there is no measuring technology available which would allow to measure continuously and quantitatively the physiological parameters, which are essential in the development of pressure injuries, over a long period of time in the clinical setting.
The goal of this pilot study is to test whether this wearable technology can be used for measurements of skin parameter and whether temperature, pressure, humidity, perfusion, and oxygenation can be measured safely and accurately.
10 healthy individuals and 10 individuals with spinal cord will be enrolled for measurements with this newly developed device over the ischium for 30 minutes. The reproducibility of the measurements will be investigated.
Detailed description
Background of the study:
Pressure injury is a major problem in patients with no or limited mobility and sensation such as paraplegics. One of the main principles to prevent development of pressure injury is to reduce the pressure over certain regions by changing the resting or lying position periodically. Paraplegics who are suffering from loss of sensation in some parts of the body are at high risk because of the missing internal trigger to change the position regularly. Many studies have addressed the personal, social, medical and economic consequences of pressure injuries. Some studies have investigated solutions aiming to reduce the probability of pressure injury development, such as special mattresses or the frequency of moving the patients from one side to the other etc. So far it has not yet been possible to quantitatively and continuously measure the physiological skin parameters, which are essential in the development of pressure injury, over a long period of time. Up to now, long-term studies on paraplegics are limited because there are no suitable measurement devices. Current measurement devices are hard and inflexible and increase the probability of pressure ulcer development in paraplegics by applying external pressure on the tissue. In this project, the applicability of wearable measuring systems, which do not apply external pressure on the tissue, will be evaluated in paraplegics.
Aim of the study:
The goal of the study is to answer the following questions:
- Is wearable technology usable for skin physiology measurements in paraplegics?
- Are the measurements of skin temperature, pressure, humidity, perfusion, and oxygenation reproducible in able bodied individuals?
- Do changes in skin temperature, pressure, humidity, perfusion, and oxygenation differ between paraplegics and healthy subjects?
Study design Two different measurement patches will be used. One patch consists of temperature, pressure, humidity and perfusion sensors. The second patch consists of near-infrared spectroscopy (NIRS) sensors (to measure oxygenation). This patch is designed for non-invasive measurement of oxygenation parameters such as oxygen saturation, oxygen consumption etc. The study is divided into two parts. The first part will be performed in 10 healthy subjects and 3 paraplegics. There will be two measurements in paraplegics and three measurements in healthy subjects, each for 10 minutes. The second part which will be conducted in 10-20 subjects (5-10 healthy and 5-10 paraplegics). The skin parameters will be measured for an hour.
Part 1a healthy subjects:
The subject will acclimatize in the room where the experiment takes place for 15 minutes. Then the patch will be placed over the ischium of the patient. Ischium will be localized manually and the patch will be placed in the underwear of the participant. The subject will be asked to sit for 10 minutes in a chair.
Part 1b paraplegics:
The subject will acclimatize in the room where the experiment takes place for 15 minutes. Then the patch will be placed over the ischium of the patient. Ischium will be localized manually and the patch will be placed in the underwear of the participant. The subject will be asked to sit for 10 minutes in a in a standard wheelchair.
Part 2:
The same procedure will be carried out with the only difference that the measurements will last 60 minutes.
Statistical Analyses:
Data will be analyzed descriptively. The reproducibility of the data will be analyzed using intraclass correlation coefficients (ICC).
The differences between data from paraplegics and that of healthy subjects will be analyzed using the Mann-Whitney-U-Test.
.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy persons | – | Device: ProTex |
| individuals with paraplegia | – | Device: ProTex |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy volunteers and individuals with paraplegia
Key inclusion criteria (2 listed)
- men and women
- age: 18 - 50 years
Key exclusion criteria (3 listed)
- Any sign of pressure ulcer or a history of pressure ulcer on the ischium
- Diabetes
- Acute infection or disease
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 |
|---|---|---|
| ProTexNon invasive measurement of pressure, temperature, humidity, perfusion, and oxygenation | Device | healthy persons, individuals with paraplegia |
Primary outcome
change of pressure on skin
Time frame: baseline and 10 minutes later
measuring skin surface pressure with a pressure sensor in the underpants
4 secondary outcomes
change in skin temperature
Time frame: baseline and 10 minutes later
change in skin perfusion
Time frame: baseline and 10 minutes later
change in skin humidity
Time frame: baseline and 10 minutes later
change in skin oxygenation
Time frame: baseline and 10 minutes later
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Skin Physiology and Spinal Cord Injuries, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 28 May 2025. 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 Switzerland. 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 was withdrawn before enrolling participants, so there are no results.
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?
change of pressure on skin (time frame: baseline and 10 minutes later). 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 28 May 2025.