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

NCT07694583 | Recruiting DMC

• 1 other identifier: RSCH ID-24-01422-IRV
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pressure Ulcer Stage 1; Pressure Ulcers Stage II; Pressure Injuries

Keywords

Dressing membrane; Tocotrienols; Wound care; Pressure Ulcer; hydrocolloid; pressure injury; PUSH score; wound size reduction

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  Day 0, Day 1, Day 3, Day 5, Day 7, Day 15, Day 22, Day 29, Day 35, Day 43

Study Arms (2)

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.

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.

Device: Conventional dressing

Interventions

Tocotrienol-loaded formulated dressing DEVICE

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.

Tocotrienol dressing

Conventional dressing DEVICE

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

Conventional dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Monash University Malaysia: lead
• Malaysia Palm Oil Board: collaborator
• University Malaysia Medical Centre: collaborator

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Selangor, 59100, Malaysia

RECRUITING

Related Publications (5)

• 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.

  PMID: 33241700 BACKGROUND

• Guo 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.

  PMID: 32028609 BACKGROUND

• Ruiz-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.

  PMID: 30395878 BACKGROUND

• Alias 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.

  PMID: 28061321 BACKGROUND

• Lin 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.

  PMID: 23097676 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Lay Hong Dr. Chuah, PHD, MPharm, R.Ph

CONTACT

+6017-3592799; alice.chuah@monash.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 10, 2026
• Study Start: January 21, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

MY (1)