Clinical Trial

Wound Dressing Patch with Kelulut Honey-Infused Alginate (Tri-Gnate Alginate) for Effective Wound Care Management

Not Yet Recruiting Early Phase 1
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Record status
This record was last updated March 13, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
The main aim of this study to effectiveness of dressing patch with Kelulut honey (Tri-Gnate Alginate) in promoting wound healing compared to conventional treatments (standard wound dressing + bactigras) and other types of medicinal honey based product (Manuka honey product). Tri-Gnate alginate is a product produced by researcher team which upgraded from raw honey into a dressing patch. 110 patients with diabetic foot ulcers is expected to enrol in this program. The patients will be assigned randomly into 3 groups namely as Group 1 - patient that will receive Tri-Gnate alginate product in their dressing, Group 2 - patient will receive Manuka honey patch product and group 3 - the patient will receive standard care (bactigras dressing + dermacyn). Prior to the applying of these dressing treatment, all the patient will receive Maggot Debridement Therapy (MDT) to ensure the wound is clean. Patient's wound condition will be monitored 7 times (T0 - T6) on alternate day basis for healing improvement.
Trial Details
NCT Number NCT06873646
Lead Sponsor Mohd Khairul Zul Hasymi Firdaus
Collaborators: Ministry of Higher Education, Malaysia
Conditions Diabetic Foot Ulcers
Enrollment 110 participants
Start Date 2025-11-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-13