Evaluating the Efficacy of a Tocotrienols-Loaded Dressing in Wound Care for Pressure Ulcers (TOCOWO)

July 4, 2026 updated by: Chuah Lay Hong, Monash University Malaysia

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?

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Selangor
      • Kuala Lumpur, Selangor, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre
        • Contact:
        • Principal Investigator:
          • Kah Seng Dr. Khoo, MBBS, MRCS, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tocotrienol dressing
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
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.
Placebo Comparator: Conventional 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
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.
Other Names:
  • Standard care of control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction 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).
Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in wound area
Time Frame: Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43
This secondary outcome measure was chosen because a greater reduction in wound area would indicate faster healing.
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
This secondary outcome measure provides an indication of the wound healing rate throughout the study.
Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monash University Malaysia

Collaborators

Malaysia Palm Oil Board
University Malaysia Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 4, 2026

First Submitted That Met QC Criteria

July 4, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 4, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSCH ID-24-01422-IRV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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