An interventional study of PU sensor in Pressure Ulcer, sponsored by PU sensor AB. Completed at 3 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-25.
Sponsored by PU sensor AB · Not applicable, Interventional, and Prevention
A double blind, non randomized, multicenter investigation
The study consists of 2 evaluations/visits.
Evaluation/visit 1: Takes place in connection with admission to the hospital. Informed consent, inclusion and exclusion criteria are assessed as well as assessment of skin type and inspection of the entire body skin. Pregnancy test on women of childbearing potential, height, weight, blood pressure and body temperature are measured. Questions about demography, health conditions, previous illnesses, nicotine habits. Risk assessment for pressure ulcers (Modified Norton or RAPS-scale) is carried out according to the hospital usual routine. Examination with PU sensor will be performed.
Evaluation/visit 2: Takes place in connection with the discharge from the hospital or 4 weeks after visit 1 if the research subject is still hospitalized. Full body skin inspection to see possible onset of pressure ulcers. Review of the research subject's medical records as well as review of nursing notes from the hospital where the research subject has been discharged from, to find any notes about pressure ulcers. The study participation is then terminated for the research subject.
517 studies on the registry are indexed under Pressure Ulcer; 116 are open to participants now.
This study's enrollment of 433 is above the median of 70 across 394 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →This is the only study on the registry with PU sensor AB as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device:PU Sensor will assess the microcirculation in sacrum with and without pressure (subject will lay on side and after that on back) the total measurement time is 5-10 minutes
Device: PU sensor
Device to assess microcirculation in sacrum area to find subjects at risk for pressure ulcer
Number of pressure ulcers developed between visit 1 and 2
This outcome is to evaluate if the subjects that have been assessed as at risk of developing pressure ulcers (using PU sensor) have actually developed pressure ulcers with a greater probability than those assessed as not at risk
Time frame: Up to 4 weeks
Incidence of adverse events (AEs) and adverse device effects (ADEs)
All adverse events (AEs) and adverse device effects (ADEs) incidence and severity following measurement with PU sensor up to 2 days after the baseline
Time frame: Up to 2 days
Proportion of pressure ulcers located in sacrum
The examination with PU sensor is in sacrum. Proportion of pressure ulcers that are located in sacrum for PU sensor high-risk group compared to PU sensor low-risk group. PU sensor high-risk group are those subjects who have a decreased blood flow at pressure from their own body, resulting in a "High risk" result from PU sensor. This proportion is compared for the two groups to evaluate if PU sensor can assess risk of pressure ulcers on the skin everywhere, or only in sacrum where the examination is done.
Time frame: Up to 4 weeks
Combine Norton/RAPS with PU Sensor results
All subject will use Norton or RAPS for risk assessment of pressure ulcer. The results from these risk assessments will be compared with the results from PU Sensor and pressure ulcers developed to explore if a combination of the scales and PU sensor would give a better view of subjects at risk.
Time frame: Up tp 4 weeks
Compare PU sensor examinations for different skin types
PU sensor is using PPG (Photoplethysmography) to assess blood flow in sacrum. Since light is used the the skin type (amount of pigment and in the skin etc) may affect the examination.
Time frame: Up to 4 weeks
Compare PU sensor examinations for subjects with underlying disease
PU sensor is using PPG (Photoplethysmography) to assess blood flow in sacrum. Underlying diseases such as Hypertension and/or Diabetes may affect the examination.
Time frame: Up to 4 weeks
Plan to share: No — Due to uncertainties in EU data protection legislation individual deidentified participant data are not shared. The main uncertainty is the concept of what "deidentified" means. It appears not to mean that the data set of a person is simply separated from the person's name. What additional operations have to be done appears to depend on technological capabilities to re-identify the persons associated with the data set. A common perception is that the technological capabilities for re-identification are permanently increasing. This could have the effect that public data sets that are regarded as deidentified now might become re-identifiable data sets in the future. Once this happens, the sponsor is no longer able to make the publication of the data sets un-happen. This could result in punishment by EU data protection authorities. The sponsor wants to avoid this.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.