Pressure Ulcer Stage 1TOCOWONCT07694583
Evaluating the Efficacy of a Tocotrienols-Loaded Dressing in Wound Care for Pressure Ulcers
A study testing Tocotrienol-loaded formulated dressing and Conventional dressing in people with Pressure Ulcer Stage 1 and Pressure Ulcers Stage II, run by Monash University Malaysia at 1 site in Malaysia.
Trial summary
The goal of this clinical trial is to investigate the effects of the dressing containing Tocotrienols on patients with stage 1 and stage 2 pressure ulcers. The main questions it aims to answer are: Will the dressing containing Tocotrienols lead to a reduction in the Pressure Ulcer Scale for Healing (PUSH) Score? Will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer Stage 1, Pressure Ulcers Stage II, Pressure Injuries
- What is being tested?
- Tocotrienol-loaded formulated dressing and Conventional dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteMalaysia
- Study dates
- 21 Jan 2026to Dec 2027
- 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
- The included participants or caretakers are older than 18 years with at least one pressure ulcer that was stage I-II as classified by the National Pressure Ulcer Advisory Panel and the European Pressure Ulcer Advisory Panel (NPUAP/EPUAP)
- Exhibited a pressure ulcer surface area of <80 cm2 (multiplication of the major and minor diameters of the wound surface)
- PUSH (version 3.0) score of >5 that was likely to heal during the 6-month study period
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
Who cannot join
- Stage III \& IV pressure ulcers requiring different standard of care
- Multiple known allergies to other types of dressings
- Wound deemed to have an infection
- Area of skin necrosis that requires special dressing and/or topical antibiotic treatment
- Any (medical) conditions that would, in the opinion of the investigator, potentially compromise the safety or compliance of the subject or may preclude the subjects' successful completion of the clinical trial
- Allergic to dressings during 24-hour pre-study allergy test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Centre
Kuala Lumpur, Selangor, 59100
Dr Hannis, +60134284092, hannis.arbaie@ummc.edu.my
Kah Seng Dr. Khoo, MBBS, MRCS, MS
About this study
Official title: A Prospective, Double-Blinded, Randomized Controlled Trial to Evaluate the Efficacy of a Formulated Dressing Containing Tocotrienols in Wound Care for Pressure Ulcers
The goal of this clinical trial is to investigate the effects of the dressing containing Tocotrienols on patients with stage 1 and stage 2 pressure ulcers. The main questions it aims to answer are:
- Will the dressing containing Tocotrienols lead to a reduction in the Pressure Ulcer Scale for Healing (PUSH) Score?
- Will the dressing containing Tocotrienols help heal the participants' pressure ulcer wounds?
- Will the dressing containing Tocotrienols lead to reduction in wound surface area?
- What is the percentage of patients with completely healed wounds by the end of the study?
Read more
Researchers will compare Tocotrienols-loaded formulated dressing to conventional dressing (standard of care as control) in pressure ulcers.
Participants will:
- Have their pressure ulcers checked by a study doctor to ensure they are infection-free and suitable ulcer fitting the inclusion criteria
- Undergo 24-hour allergy testing with patch of Tocotrienol-loaded dressing and standard hydrocolloid dressing
- Be randomly assigned to one of three groups if they qualify: control, vehicle-control, or treatment group
- Assess skin sensitivity testing the next day, and if qualify, will be started on first dosing.
- Attend follow-up visits on days 1, 3, 5, 7, 15, 22, 29, 35 and 43, where additional questions and assessments will be completed.
Read the detailed description
The purpose of this study is to investigate the effects of the dressing containing Tocotrienols on patients with pressure ulcers. This research is necessary because pressure ulcers is common in patient with critical illness and bedbound. Therefore, proper wound care management is crucial. Tocotrienols has been proven to have numerous health benefits, and in this study, its use will be investigated for pressure ulcers in human subjects. A total of 114 participants from patients admitted to UMMC (University Malaya Medical Centre) will be participating in this study. The whole study will last about 3 years and each participant will last about 43 days or 6 weeks.
This study is important because it is hypothesised that the Tocotrienols-loaded wound dressing will be able to reduce wound complications on application through its anti-inflammatory, anti-oxidant and wound healing effects, and provide better wound care outcome. This study also provides fundamental groundwork to expand the use of Tocotrienols in surgical and non-surgical wound management, as well as scar reduction in aesthetic and cosmetic applications.
The participants that are invited to participate in the research study because they have pressure ulcers that requires Tocotrienols-loaded formulated dressing. Participants should not take part in this study if they have multiple known allergies to various types of dressings, if their wound is determined to be infected, or if there are of skin necrosis requires special dressing and topical antibiotic treatment. Additionally, individuals with any medical conditions that, in the investigator's opinion, could potentially compromise their safety, adherence, or ability to successfully complete the clinical trial will also be excluded from participation.
This is a double-blinded randomized controlled trial. The procedure that is being tested is a Tocotrienols-loaded formulated dressing on Stage 1 and Stage 2 pressure ulcers. The participants will be randomly assigned to one of the treatment groups below:
Group 1: Tocotrienols-loaded formulated dressing Group 2: Conventional hydrocolloid dressing (standard of care as control) Neither the participants nor the doctor will know which group the participants are assigned to but in the case of emergencies, this information will be available to the doctor.
During the length of the study, the participants involvement will include:
- Being screened by the study doctor, who will examine their pressure ulcers and recruit them if they are eligible.
- If eligible, they will be randomly assigned to either the control or treatment group.
- Undergo 24-hour allergy testing with patch of Tocotrienol-loaded dressing and standard hydrocolloid dressing
- Assess skin sensitivity testing the next day, and if qualify, will be started on first dosing.
- Attend follow-up visits on days 3, 5, 7, 15, 22, 29, 35 and 43, where additional questions and assessments will be completed.
This study is sponsored by the Malaysian Palm Oil Board (MPOB) who will pay for all study products and procedures. All the information obtained in this study will be kept and handled in a confidential manner, in accordance with applicable laws and/or regulations. Data from the study may be archived for the purpose of analysis, but the participants' identity will not be revealed at any time.
- Being tested
- Tocotrienol-loaded formulated dressing, Conventional dressing
- Keywords
- Dressing membrane, Tocotrienols, Wound care, Pressure Ulcer, hydrocolloid, pressure injury, PUSH score, wound size reduction
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocotrienol-loaded formulated dressingDevice
Tocotrienol-loaded formulated dressing is designed as all-in-one easy to use dressing. This is the first dressing formulated to contain tocotrienols. The dressing is expected to speed up the healing process compared to control.
Conventional dressingDevice
Also called Standard care of control
The standard care serves as a control, using a conventional hydrocolloid dressing. This control group allows for a comparison with the intervention to assess differences in outcomes at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Tocotrienol dressing | Experimental | Participants in this experimental arm will receive a Tocotrienol-loaded dressing. The dressing will be applied topically to the affected area, and the treatment will continue for a duration of 6 weeks. Receives: Device: Tocotrienol-loaded formulated dressing |
| Conventional dressing | Placebo comparator | Participants in this experimental arm will receive a conventional dressing as standard care (control). The dressing will be applied topically to the affected area, and the treatment will continue for a duration of 6 weeks. Receives: Device: Conventional dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pressure Ulcer Scale for Healing (PUSH) score
This primary outcome measure was developed by The National Pressure Ulcer Advisory Panel to monitor pressure healing over time. The range of the score is 0-17, that is, from completely healed to the greatest severity. The scale consists of 3 domains: length times width (10-scale), exudate amount (none, light, moderate, and heavy), and tissue type (necrotic tissue, slough, granulation tissue, epithelial tissue and closed wound).
Measured: Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43
Secondary outcomes (2)
Change in total wound surface area
This secondary outcome measure was chosen because a greater reduction in total wound surface area would indicate faster healing. The surface area will be measured using digital wound imaging app.
Measured: Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43
Percentage of patients with completely healed wound
This secondary outcome measure provides an indication of the wound healing rate throughout the study.
Measured: Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start21 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pressure Ulcer Stage 1Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysia Palm Oil Board, University of Malaya
- Responsible party
- Principal investigator, Chuah Lay Hong, Monash University Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694583
- Sponsor's protocol ID
- RSCH ID-24-01422-IRV
- Acronym
- TOCOWO
- Status last verified
- Jul 2026
- First submitted
- 4 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guo HF, Mohd Ali R, Abd Hamid R, Chang SK, Rahman MH, Zainal Z, Khaza'ai H. Epidermal Growth Factor and Tocotrienol-Rich Fraction Cream Formulation Accelerates Burn Healing Process Based on Its Gene Expression Pattern in Deep Partial-Thickness Burn Wound Model. Int J Low Extrem Wounds. 2022 Dec;21(4):544-554. doi: 10.1177/1534734620971066. Epub 2020 Nov 26.
PubMed 33241700Guo HF, Abd Hamid R, Mohd Ali R, Chang SK, Rahman MH, Zainal Z, Khaza'ai H. Healing Properties of Epidermal Growth Factor and Tocotrienol-Rich Fraction in Deep Partial-Thickness Experimental Burn Wounds. Antioxidants (Basel). 2020 Feb 3;9(2):130. doi: 10.3390/antiox9020130.
PubMed 32028609Ruiz-Tovar J, Llavero C, Perez-Lopez M, Garcia-Marin A. Effects of the application of vitamin E and silicone dressings vs conventional dressings on incisional surgical site infection in elective laparoscopic colorectal surgery: a prospective randomized clinical trial. J Hosp Infect. 2019 Jul;102(3):262-266. doi: 10.1016/j.jhin.2018.10.021. Epub 2018 Nov 3.
PubMed 30395878Alias D, Ruiz-Tovar J, Moreno A, Manso B, Diaz G, Duran M, Garcia-Olmo D. Effect of Subcutaneous Sterile Vitamin E Ointment on Incisional Surgical Site Infection after Elective Laparoscopic Colorectal Cancer Surgery. Surg Infect (Larchmt). 2017 Apr;18(3):287-292. doi: 10.1089/sur.2016.199. Epub 2017 Jan 6.
PubMed 28061321Lin TS, Abd Latiff A, Abd Hamid NA, Wan Ngah WZ, Mazlan M. Evaluation of topical tocopherol cream on cutaneous wound healing in streptozotocin-induced diabetic rats. Evid Based Complement Alternat Med. 2012;2012:491027. doi: 10.1155/2012/491027. Epub 2012 Oct 14.
PubMed 23097676
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-Blinded, Randomized Controlled Trial to Evaluate the Efficacy of a Formulated Dressing Containing Tocotrienols in Wound Care for Pressure Ulcers
- ClinicalTrials.gov ID
- NCT07694583
- Acronym / sponsor ID
- TOCOWO / RSCH ID-24-01422-IRV
- Keywords
- Dressing membrane, Tocotrienols, Wound care, Pressure Ulcer, hydrocolloid, pressure injury, PUSH score, wound size reduction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Monash University MalaysiaUniversity, hospital or other
- Collaborators
- Malaysia Palm Oil Board, University of Malaya
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Jul 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.
The goal of this clinical trial is to investigate the effects of the dressing containing Tocotrienols on patients with stage 1 and stage 2 pressure ulcers. The main questions it aims to answer are:
- Will the dressing containing Tocotrienols lead to a reduction in the Pressure Ulcer Scale for Healing (PUSH) Score?
- Will the dressing containing Tocotrienols help heal the participants' pressure ulcer wounds?
- Will the dressing containing Tocotrienols lead to reduction in wound surface area?
- What is the percentage of patients with completely healed wounds by the end of the study?
Researchers will compare Tocotrienols-loaded formulated dressing to conventional dressing (standard of care as control) in pressure ulcers.
Participants will:
- Have their pressure ulcers checked by a study doctor to ensure they are infection-free and suitable ulcer fitting the inclusion criteria
- Undergo 24-hour allergy testing with patch of Tocotrienol-loaded dressing and standard hydrocolloid dressing
- Be randomly assigned to one of three groups if they qualify: control, vehicle-control, or treatment group
- Assess skin sensitivity testing the next day, and if qualify, will be started on first dosing.
- Attend follow-up visits on days 1, 3, 5, 7, 15, 22, 29, 35 and 43, where additional questions and assessments will be completed.
Detailed description
The purpose of this study is to investigate the effects of the dressing containing Tocotrienols on patients with pressure ulcers. This research is necessary because pressure ulcers is common in patient with critical illness and bedbound. Therefore, proper wound care management is crucial. Tocotrienols has been proven to have numerous health benefits, and in this study, its use will be investigated for pressure ulcers in human subjects. A total of 114 participants from patients admitted to UMMC (University Malaya Medical Centre) will be participating in this study. The whole study will last about 3 years and each participant will last about 43 days or 6 weeks.
This study is important because it is hypothesised that the Tocotrienols-loaded wound dressing will be able to reduce wound complications on application through its anti-inflammatory, anti-oxidant and wound healing effects, and provide better wound care outcome. This study also provides fundamental groundwork to expand the use of Tocotrienols in surgical and non-surgical wound management, as well as scar reduction in aesthetic and cosmetic applications.
The participants that are invited to participate in the research study because they have pressure ulcers that requires Tocotrienols-loaded formulated dressing. Participants should not take part in this study if they have multiple known allergies to various types of dressings, if their wound is determined to be infected, or if there are of skin necrosis requires special dressing and topical antibiotic treatment. Additionally, individuals with any medical conditions that, in the investigator's opinion, could potentially compromise their safety, adherence, or ability to successfully complete the clinical trial will also be excluded from participation.
This is a double-blinded randomized controlled trial. The procedure that is being tested is a Tocotrienols-loaded formulated dressing on Stage 1 and Stage 2 pressure ulcers. The participants will be randomly assigned to one of the treatment groups below:
Group 1: Tocotrienols-loaded formulated dressing Group 2: Conventional hydrocolloid dressing (standard of care as control) Neither the participants nor the doctor will know which group the participants are assigned to but in the case of emergencies, this information will be available to the doctor.
During the length of the study, the participants involvement will include:
- Being screened by the study doctor, who will examine their pressure ulcers and recruit them if they are eligible.
- If eligible, they will be randomly assigned to either the control or treatment group.
- Undergo 24-hour allergy testing with patch of Tocotrienol-loaded dressing and standard hydrocolloid dressing
- Assess skin sensitivity testing the next day, and if qualify, will be started on first dosing.
- Attend follow-up visits on days 3, 5, 7, 15, 22, 29, 35 and 43, where additional questions and assessments will be completed.
This study is sponsored by the Malaysian Palm Oil Board (MPOB) who will pay for all study products and procedures. All the information obtained in this study will be kept and handled in a confidential manner, in accordance with applicable laws and/or regulations. Data from the study may be archived for the purpose of analysis, but the participants' identity will not be revealed at any time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocotrienol dressing | Experimental | Device: Tocotrienol-loaded formulated dressingParticipants in this experimental arm will receive a Tocotrienol-loaded dressing. The dressing will be applied topically to the affected area, and the treatment will continue for a duration of 6 weeks. |
| Conventional dressing | Placebo comparator | Device: Conventional dressingParticipants in this experimental arm will receive a conventional dressing as standard care (control). The dressing will be applied topically to the affected area, and the treatment will continue for a duration of 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The included participants or caretakers are older than 18 years with at least one pressure ulcer that was stage I-II as classified by the National Pressure Ulcer Advisory Panel and the European Pressure Ulcer Advisory Panel (NPUAP/EPUAP)
- Exhibited a pressure ulcer surface area of <80 cm2 (multiplication of the major and minor diameters of the wound surface)
- PUSH (version 3.0) score of >5 that was likely to heal during the 6-month study period
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
Key exclusion criteria (6 listed)
- Stage III \& IV pressure ulcers requiring different standard of care
- Multiple known allergies to other types of dressings
- Wound deemed to have an infection
- Area of skin necrosis that requires special dressing and/or topical antibiotic treatment
- Any (medical) conditions that would, in the opinion of the investigator, potentially compromise the safety or compliance of the subject or may preclude the subjects' successful completion of the clinical trial
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 |
|---|---|---|
| Tocotrienol-loaded formulated dressingTocotrienol-loaded formulated dressing is designed as all-in-one easy to use dressing. This is the first dressing formulated to contain tocotrienols. The dressing is expected to speed up the healing process compared to control. | Device | Tocotrienol dressing |
| Conventional dressingAlso: Standard care of controlThe standard care serves as a control, using a conventional hydrocolloid dressing. This control group allows for a comparison with the intervention to assess differences in outcomes at the end of the study. | Device | Conventional dressing |
Primary outcome
Change in Pressure Ulcer Scale for Healing (PUSH) score
Time frame: Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43
This primary outcome measure was developed by The National Pressure Ulcer Advisory Panel to monitor pressure healing over time. The range of the score is 0-17, that is, from completely healed to the greatest severity. The scale consists of 3 domains: length times width (10-scale), exudate amount (none, light, moderate, and heavy), and tissue type (necrotic tissue, slough, granulation tissue, epithelial tissue and closed wound).
2 secondary outcomes
Change in total wound surface area
Time frame: Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43
Percentage of patients with completely healed wound
Time frame: Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43
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 15 Jul 2026.
- Background: PubMed 33241700Guo HF, Mohd Ali R, Abd Hamid R, Chang SK, Rahman MH, Zainal Z, Khaza'ai H. Epidermal Growth Factor and Tocotrienol-Rich Fraction Cream Formulation Accelerates Burn Healing Process Based on Its Gene Expression Pattern in Deep Partial-Thickness Burn Wound Model. Int J Low Extrem Wounds. 2022 Dec;21(4):544-554. doi: 10.1177/1534734620971066. Epub 2020 Nov 26.
- Background: PubMed 32028609Guo HF, Abd Hamid R, Mohd Ali R, Chang SK, Rahman MH, Zainal Z, Khaza'ai H. Healing Properties of Epidermal Growth Factor and Tocotrienol-Rich Fraction in Deep Partial-Thickness Experimental Burn Wounds. Antioxidants (Basel). 2020 Feb 3;9(2):130. doi: 10.3390/antiox9020130.
- Background: PubMed 30395878Ruiz-Tovar J, Llavero C, Perez-Lopez M, Garcia-Marin A. Effects of the application of vitamin E and silicone dressings vs conventional dressings on incisional surgical site infection in elective laparoscopic colorectal surgery: a prospective randomized clinical trial. J Hosp Infect. 2019 Jul;102(3):262-266. doi: 10.1016/j.jhin.2018.10.021. Epub 2018 Nov 3.
- Background: PubMed 28061321Alias D, Ruiz-Tovar J, Moreno A, Manso B, Diaz G, Duran M, Garcia-Olmo D. Effect of Subcutaneous Sterile Vitamin E Ointment on Incisional Surgical Site Infection after Elective Laparoscopic Colorectal Cancer Surgery. Surg Infect (Larchmt). 2017 Apr;18(3):287-292. doi: 10.1089/sur.2016.199. Epub 2017 Jan 6.
- Background: PubMed 23097676Lin TS, Abd Latiff A, Abd Hamid NA, Wan Ngah WZ, Mazlan M. Evaluation of topical tocopherol cream on cutaneous wound healing in streptozotocin-induced diabetic rats. Evid Based Complement Alternat Med. 2012;2012:491027. doi: 10.1155/2012/491027. Epub 2012 Oct 14.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tocotrienol-loaded formulated dressing and Conventional dressing in people with Pressure Ulcer Stage 1 and Pressure Ulcers Stage II, run by Monash University Malaysia at 1 site in Malaysia.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Jul 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 Malaysia. 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. Some participants in this study may receive a placebo. 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?
Contact Lay Hong Dr. Chuah, PHD, MPharm, R.Ph (+6017-3592799, alice.chuah@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pressure Ulcer Scale for Healing (PUSH) score (time frame: Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07694583, which also lists 5 linked publications.
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 15 Jul 2026.