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

4 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

114

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Malaysia
    • Selangor
      • Kuala Lumpur, Selangor, Malaysia, 59100
        • Reclutamento
        • University Malaya Medical Centre
        • Contatto:
        • Investigatore principale:
          • Kah Seng Dr. Khoo, MBBS, MRCS, MS

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Comparatore placebo: 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.
Dispositivo: 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.
Altri nomi:
  • Standard care of control

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Reduction in Pressure Ulcer Scale for Healing (PUSH) score
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Reduction in wound area
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Monash University Malaysia

Collaboratori

Malaysia Palm Oil Board
University Malaysia Medical Centre

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

21 gennaio 2026

Completamento primario (Stimato)

1 dicembre 2027

Completamento dello studio (Stimato)

1 dicembre 2027

Date di iscrizione allo studio

Primo inviato

4 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 luglio 2026

Primo Inserito (Effettivo)

10 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RSCH ID-24-01422-IRV

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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