New ultrasound tool could predict bedsores before they form
NCT ID NCT07496411
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether an ultrasound-based risk score can better predict and prevent pressure injuries (bedsores) in critically ill ICU patients. In phase 1, researchers will check how accurately the score identifies high-risk patients. In phase 2, some patients will receive nursing care guided by the ultrasound score, while others get standard care. The goal is to see if the new approach reduces bedsores.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ultrasound-based Quantitative Risk Score-guided Nursing Intervention
- What this could lead to
- If successful, this could provide a more accurate way to predict and prevent pressure injuries in critically ill patients, reducing suffering and healthcare costs.
- What could go wrong
- This is an early-stage study with only 390 participants. The ultrasound score may not prove more effective than current methods, and results may not apply to all ICU settings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 390 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Phase 1: Tool Development and Validation (Observational) Inclusion Criteria (Phase 1): 1. Age \> 18 years. 2. Newly admitted to the Intensive Care Unit (ICU) with an expected stay of ≥ 96 hours. 3. Intact skin in the sacrococcygeal region within 24 hours of ICU admission. 4. Provision of signed informed consent. Exclusion Criteria (Phase 1): 1. Pregnant women or children. 2. Skin conditions (e.g., scarring, burns, or tumors) in the sacrococcygeal region interfering with ultrasound. 3. Clinical instability preventing lateral repositioning for ultrasound. 4. History of major sacrococcygeal surgery or severe trauma. 5. Life expectancy \< 48 hours. Phase 2: Randomized Controlled Trial (Interventional) Inclusion Criteria (Phase 2): 1. Meet all the general inclusion criteria from Phase 1. 2. Meet the pre-defined risk threshold based on the Ultrasound-based Quantitative Risk Score, as determined from the analysis of Phase 1 results. Exclusion Criteria (Phase 2): 1. Meet all the general exclusion criteria from Phase 1. 2. Previous participation in Phase 1 of this study (to maintain independent samples for the RCT). 3. Current participation in other interventional trials that may impact pressure injury outcomes.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Other studies related to the condition(s) this trial covers.
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