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Vitamin e dressing may speed healing of bedsores

NCT ID NCT07694583

Disease control Sponsor: Monash University Malaysia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This trial tests whether a special dressing containing tocotrienols (a form of vitamin E) helps heal stage 1 and 2 pressure ulcers (bedsores) faster than standard care. About 114 adults with pressure ulcers will be randomly assigned to receive either the tocotrienol dressing or a conventional hydrocolloid dressing. Researchers will measure wound healing over 43 days using the Pressure Ulcer Scale for Healing (PUSH) score and wound size reduction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tocotrienol-loaded formulated dressing
What this could lead to
If effective, this dressing could speed up healing of pressure ulcers and reduce wound size, offering a simple new option for wound care.
What could go wrong
This is a small, early-stage trial, so results may not apply broadly. The dressing may not heal wounds faster than standard care, and some people may have skin reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 114 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

decubitus ulcer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pressure injuries Pressure ulcer stage 1 Pressure ulcers stage II

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University Malaya Medical Centre

    RECRUITING

    Kuala Lumpur, Selangor, 59100, Malaysia

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