Pressure UlcerNCT05458050
An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers
A study testing PU sensor in people with Pressure Ulcer, run by PU sensor AB at 3 sites in Sweden.
Trial summary
A double blind, non randomized, multicenter investigation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- PU sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Sep 2022to 24 Aug 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Given their written consent to participate in the study
- Male or female between ≥18 years and ≤ 64 years with a reduced mobility, where the hospitalization may involve a risk that the person may become less active or Male or female ≥65 years
Who cannot join
- Existing pressure ulcer or damage to the skin around the sacrum where the PU sensor plate and pillow are to be placed
- Fever ≥38 ºC, within 30 minutes before the examination with PU sensor
- Difficulty lying still in supine position during the examination with PU sensor, which takes 5 to 10 minutes
- Known allergy or sensitivity to any of the materials in PU sensor that gets in contact with the skin on the sacrum
- Body weight ≥200 kg
- Previous participation in the study
- Mental inability, or language difficulties that results in difficulty to understand the meaning of participation in the study and / or signing the study consent,
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Länssjukhuset Ryhov, Geriatriska kliniken
Jönköping, 55185
Oskarhamns Sjukhus
Oskarshamn, 57251
Medicin-Geriatriska kliniken Akademiska sjukhuset,
Uppsala, 75185
About this study
Official title: A Double-blind, Intervention, Post-marketing Investigation to Identify Subjects Who Are Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers, Using PU Sensor
A double blind, non randomized, multicenter investigation
Read the detailed description
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.
- Conditions
- Pressure Ulcer
- Being tested
- PU sensor
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PU sensorDevice
Device to assess microcirculation in sacrum area to find subjects at risk for pressure ulcer
| Study group | Role | What they receive |
|---|---|---|
| PU Sensor examination | Other | 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 Receives: Device: PU sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 4 weeks
Secondary outcomes (1)
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
Measured: Up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Sep 2022
- Primary completion30 Jun 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Double blind
- Masking
- None (open label)
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- PU sensor AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aurevia
- Responsible party
- Sponsor
- Investigators
- Anna-Christina Ek, RN,PhD, Study chair, PU Sensor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458050
- Sponsor's protocol ID
- CIP-PUS-1-001
- Status last verified
- Aug 2023
- First submitted
- 15 Jun 2022
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Intervention, Post-marketing Investigation to Identify Subjects Who Are Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers, Using PU Sensor
- ClinicalTrials.gov ID
- NCT05458050
- Acronym / sponsor ID
- CIP-PUS-1-001
- Conditions
- Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- PU sensor ABIndustry (pharma, biotech, devices)
- Collaborators
- Aurevia
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 14 Jul 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.
A double blind, non randomized, multicenter investigation
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Double blind
| Arm | Type | Receives |
|---|---|---|
| PU Sensor examination | Other | Device: PU sensorDevice: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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Given their written consent to participate in the study
- Male or female between ≥18 years and ≤ 64 years with a reduced mobility, where the hospitalization may involve a risk that the person may become less active or Male or female ≥65 years
Key exclusion criteria (8 listed)
- Existing pressure ulcer or damage to the skin around the sacrum where the PU sensor plate and pillow are to be placed
- Fever ≥38 ºC, within 30 minutes before the examination with PU sensor
- Difficulty lying still in supine position during the examination with PU sensor, which takes 5 to 10 minutes
- Known allergy or sensitivity to any of the materials in PU sensor that gets in contact with the skin on the sacrum
- Body weight ≥200 kg
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 |
|---|---|---|
| PU sensorDevice to assess microcirculation in sacrum area to find subjects at risk for pressure ulcer | Device | PU Sensor examination |
Primary outcome
Number of pressure ulcers developed between visit 1 and 2
Time frame: Up to 4 weeks
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
1 secondary outcome
Incidence of adverse events (AEs) and adverse device effects (ADEs)
Time frame: Up to 2 days
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 25 Aug 2023.
- Individual participant dataSharing planned: 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.
Related trials for Pressure Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers
Neuropathic Ulcers
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
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.
Anna-Christina Ek, RN,PhD study chair
PU Sensor
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PU sensor in people with Pressure Ulcer, run by PU sensor AB at 3 sites in Sweden.
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 8 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 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
Number of pressure ulcers developed between visit 1 and 2 (time frame: Up to 4 weeks). 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 25 Aug 2023.