Tocotrienol-loaded Dressing for Stage 1–2 Pressure Ulcers
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
Run by Monash University Malaysia · NCT07694583 · Data updated 2026-11-12
Atocotrienol-containing wound dressing is being tested to see if it helps heal stage 1–2 pressure ulcers better than standard dressings.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 114 (estimated) |
| Sponsor | Monash University Malaysia Academic / other |
| Locations | 1 site (Kuala Lumpur, Selangor) |
| Status | Recruiting |
| Started | January 21, 2026 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | July 15, 2026 |
| Trial ID | NCT07694583 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with at least one stage I–II pressure ulcer, ulcer area <80 cm2, and a PUSH score >5 likely to heal within six months.
✕Probably not a fit
Patients with stage III–IV ulcers, infected wounds, extensive necrosis, or known allergies to dressings may not benefit and are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study tests a tocotrienol-loaded dressing against conventional care in adults with stage 1 or stage 2 pressure ulcers. Participants will be randomized to receive either the tocotrienol dressing or a standard hydrocolloid dressing and will be monitored for changes in wound size, healing progress, and PUSH scores over about six weeks per participant. Allergy testing with patches is performed to assess tolerance. The trial aims to determine whether the tocotrienol dressing can reduce wound surface area, lower PUSH scores, and increase complete wound healing rates, potentially improving wound care outcomes for bedridden or critically ill patients. The study will enroll up to 114 participants at University Malaya Medical Centre in Kuala Lumpur over a period of up to three years.
Why it matters
Potential benefit: If successful, patients may experience faster healing and better wound outcomes with a tocotrienol-containing dressing.
How similar studies have gone: Previous research suggests tocotrienols have anti-inflammatory and wound-healing properties, but this specific dressing approach for pressure ulcers is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
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University Malaya Medical Centre
Kuala Lumpur, Selangor, Malaysia Recruiting
Study contacts
- Study coordinator: Lay Hong Dr. Chuah, PHD, MPharm, R.Ph
- Email: alice.chuah@monash.edu
- Phone: +6017-3592799
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.