An interventional study of Tocotrienol-loaded formulated dressing and Conventional dressing in Pressure Ulcer Stage 1, Pressure Ulcers Stage II and Pressure Injuries, sponsored by Monash University Malaysia. Recruiting at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Monash University Malaysia · Not applicable, Interventional, and Treatment
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:
Researchers will compare Tocotrienols-loaded formulated dressing to conventional dressing (standard of care as control) in pressure ulcers.
Participants will:
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:
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.
545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.
This study's planned enrollment of 114 is above the median of 70 across 405 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Monash University Malaysia is the lead sponsor of 14 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Tocotrienol-loaded formulated dressing
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.
Device: Conventional dressing
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.
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.
Also known as: Standard care of control
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).
Time frame: Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43
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.
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
This secondary outcome measure provides an indication of the wound healing rate throughout the study.
Time frame: Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43
Plan to share: Undecided
Started Jan 2026 (actual). Primary completion is estimated for Dec 2027, 23 months after the start.
Of 179 non-industry interventional studies with no phase under Pressure Ulcer, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 23 months is above that.
Counting every sponsor, half of 209 studies reached it within 11 months; a quarter within 5 and three quarters within 28.
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Monash University Malaysia