WithdrawnNot Applicable

Intelligent Underwear (IU) in Paraplegics

Stopped: responsible parties no longer available

Switzerland0Started 2022-10-01

Plain-language 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. 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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * men and women * age: 18 - 50 years Exclusion Criteria: * Any sign of pressure ulcer or a history of pressure ulcer on the ischium * Diabetes * Acute infection or disease

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

change of pressure on skin

Timeframe: baseline and 10 minutes later

Trial details

NCT IDNCT04008160

SponsorSwiss Paraplegic Research, Nottwil

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2023-06-01

View on ClinicalTrials.gov More Skin Physiology trials