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

NCT07694583 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-07-15

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Malaysia Palm Oil Board

    collaborator OTHER_GOV

  • University of Malaya

    collaborator OTHER

  • Monash University Malaysia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-21
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Malaysia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07694583 on ClinicalTrials.gov