Pressure Ulcer PreventionNCT07547254
Evaluation of the Efficacy and Safety of Palmitoleic Acid Oil Composition in Preventing Pressure Injuries
A study testing Topical POA Oil Composition Application for Pressure Injury Prevention in people with Pressure Ulcer Prevention, run by Ruijin Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of a topical palmitoleic acid (POA) oil composition in preventing PIs and reversing Stage I damage using an integrated physiological monitoring approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer Prevention
- What is being tested?
- Topical POA Oil Composition Application for Pressure Injury Prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult inpatients (aged above 18 years).
- High risk for sacral pressure injuries, objectively defined by an abnormal hydration status (Sacral Subepidermal Moisture [SEM] Delta > 0.5) at screening.
Who cannot join
- Medical contraindications to standard repositioning protocols (e.g., unstable pelvic fractures).
- Use of topical medications or advanced prophylactic dressings on the sacrum within 14 days prior to enrollment.
- Active peripheral vascular disease significantly impairing local tissue perfusion.
- Documented hypersensitivity to the investigational product (POA) or its vehicle components.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
To evaluate the efficacy and safety of a topical palmitoleic acid (POA) oil composition in preventing PIs and reversing Stage I damage using an integrated physiological monitoring approach.
Read the detailed description
A prospective, single-center, self-controlled study was conducted enrolling adult inpatients at high risk for PIs (SEM >0.5) or with existing Stage I PIs from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine . Participants received standard preventive care plus topical POA oil composition (1 mL to sacral area, 4 times daily for 14 days). Primary outcomes included changes in SEM and TcPO₂. Assessments were performed at baseline, day 7, and day 14.
- Conditions
- Pressure Ulcer Prevention
- Being tested
- Topical POA Oil Composition Application for Pressure Injury Prevention
- Keywords
- pressure injury, Palmitoleic acid, skin care
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical POA Oil Composition Application for Pressure Injury PreventionCombination product
Topical application of 1 mL POA oil composition to the sacrococcygeal region four times daily (08:00, 12:00, 16:00, 20:00) for 14 consecutive days, with gentle spreading of the product without rubbing.
| Study group | Role | What they receive |
|---|---|---|
| Impact of Topical POA Oil on Pressure Injury Outcomes and Skin Health in Hospitalized Adults | Experimental | All participants receive standardized preventive care, including two-hourly repositioning, appropriate positioning support, and skin hygiene maintenance. The intervention comprised topical application of 1 mL POA oil composition to the sacrococcygeal region four times daily (08:00, 12:00, 16:00, 20:00) for 14 consecutive days, with gentle spreading of the product without rubbing. Receives: Combination Product: Topical POA Oil Composition Application for Pressure Injury Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subepidermal Moisture (SEM) Value
Subepidermal moisture, an early biomarker for localized tissue edema and inflammation preceding visually apparent sacral pressure injuries, will be measured exclusively at the sacrum using the Provizio® SEM Scanner. The key metric is the Sacral SEM Delta, representing the maximum biocapacitance variance between the sacral bony prominence and adjacent healthy tissue. An SEM Delta exceeding 0.5 is operationalized as the threshold for abnormal subepidermal inflammation and increased localized PI risk.
Measured: Assessed at baseline, 7 days, and 14 days post-enrollment.
Secondary outcomes (1)
Transcutaneous Partial Pressure of Oxygen (TcPO₂) changes
TcPO₂, a non-invasive indicator of local microvascular perfusion and tissue oxygenation, will be quantified using the TCM 4 monitor. The measurement will be taken at the sacrum . The outcome is reported as an absolute value in millimeters of mercury (mmHg). A TcPO₂ reading below 40 mmHg is operationalized as localized tissue hypoxia and compromised blood flow, signifying an elevated risk for pressure injury development.
Measured: Baseline, Day 7, and Day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Dec 2025
- Primary completion1 Jun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcer PreventionStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, single-center, self-controlled study was conducted enrolling adult inpatients at high risk for PIs (SEM \>0.5) or with existing Stage I PIs . Participants received standard preventive care plus topical POA oil composition (1 mL to sacral area, 4 times daily for 14 days). Primary outcomes included PI incidence, Stage I reversal rate, and changes in SEM and TcPO₂. Assessments were performed at baseline, day 7, and day 14.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547254
- Sponsor's protocol ID
- CTP202512
- Status last verified
- Dec 2025
- First submitted
- 14 Dec 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated or analysed during the current study are not publicly available due to restrictions by the ethics to protect participant privacy. Data may be available from the corresponding author upon reasonable request and with appropriate approvals.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Palmitoleic Acid Oil Composition in Preventing Pressure Injuries
- ClinicalTrials.gov ID
- NCT07547254
- Acronym / sponsor ID
- CTP202512
- Conditions
- Pressure Ulcer Prevention
- Keywords
- pressure injury, Palmitoleic acid, skin care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Apr 2026 (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.
To evaluate the efficacy and safety of a topical palmitoleic acid (POA) oil composition in preventing PIs and reversing Stage I damage using an integrated physiological monitoring approach.
Detailed description
A prospective, single-center, self-controlled study was conducted enrolling adult inpatients at high risk for PIs (SEM >0.5) or with existing Stage I PIs from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine . Participants received standard preventive care plus topical POA oil composition (1 mL to sacral area, 4 times daily for 14 days). Primary outcomes included changes in SEM and TcPO₂. Assessments were performed at baseline, day 7, and day 14.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, single-center, self-controlled study was conducted enrolling adult inpatients at high risk for PIs (SEM >0.5) or with existing Stage I PIs . Participants received standard preventive care plus topical POA oil composition (1 mL to sacral area, 4 times daily for 14 days). Primary outcomes included PI incidence, Stage I reversal rate, and changes in SEM and TcPO₂. Assessments were performed at baseline, day 7, and day 14.
| Arm | Type | Receives |
|---|---|---|
| Impact of Topical POA Oil on Pressure Injury Outcomes and Skin Health in Hospitalized Adults | Experimental | Combination Product: Topical POA Oil Composition Application for Pressure Injury PreventionAll participants receive standardized preventive care, including two-hourly repositioning, appropriate positioning support, and skin hygiene maintenance. The intervention comprised topical application of 1 mL POA oil composition to the sacrococcygeal region four times daily (08:00, 12:00, 16:00, 20:00) for 14 consecutive days, with gentle spreading of the product without rubbing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult inpatients (aged above 18 years).
- High risk for sacral pressure injuries, objectively defined by an abnormal hydration status (Sacral Subepidermal Moisture [SEM] Delta > 0.5) at screening.
Key exclusion criteria (4 listed)
- Medical contraindications to standard repositioning protocols (e.g., unstable pelvic fractures).
- Use of topical medications or advanced prophylactic dressings on the sacrum within 14 days prior to enrollment.
- Active peripheral vascular disease significantly impairing local tissue perfusion.
- Documented hypersensitivity to the investigational product (POA) or its vehicle components.
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 |
|---|---|---|
| Topical POA Oil Composition Application for Pressure Injury PreventionTopical application of 1 mL POA oil composition to the sacrococcygeal region four times daily (08:00, 12:00, 16:00, 20:00) for 14 consecutive days, with gentle spreading of the product without rubbing. | Combination product | Impact of Topical POA Oil on Pressure Injury Outcomes and Skin Health in Hospitalized Adults |
Primary outcome
Subepidermal Moisture (SEM) Value
Time frame: Assessed at baseline, 7 days, and 14 days post-enrollment.
Subepidermal moisture, an early biomarker for localized tissue edema and inflammation preceding visually apparent sacral pressure injuries, will be measured exclusively at the sacrum using the Provizio® SEM Scanner. The key metric is the Sacral SEM Delta, representing the maximum biocapacitance variance between the sacral bony prominence and adjacent healthy tissue. An SEM Delta exceeding 0.5 is operationalized as the threshold for abnormal subepidermal inflammation and increased localized PI risk.
1 secondary outcome
Transcutaneous Partial Pressure of Oxygen (TcPO₂) changes
Time frame: Baseline, Day 7, and Day 14.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No. The datasets generated or analysed during the current study are not publicly available due to restrictions by the ethics to protect participant privacy. Data may be available from the corresponding author upon reasonable request and with appropriate approvals.
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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.
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?
A study testing Topical POA Oil Composition Application for Pressure Injury Prevention in people with Pressure Ulcer Prevention, run by Ruijin Hospital at 1 site in China.
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 4 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: enrolling by invitation, as of the sponsor's last update on 23 Apr 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Subepidermal Moisture (SEM) Value (time frame: Assessed at baseline, 7 days, and 14 days post-enrollment.). 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 23 Apr 2026.