NCT06873646

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

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Mohd Khairul Zul Hasymi Firdaus · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Tri-Gnate Alginate Dressing	Patient will receive dressing product (Tri-Gnate Alginate) for the management of wound. The product will be put on every alternate day. Wound condition will be monitored from T0 - T6.
COMBINATION_PRODUCT	Dressing product from Manuka honey	Patient will receive other type of dressing product (Manuka honey product) for the management of wound. The product will be put on every alternate day. Wound condition will be monitored from T0 - T6.
COMBINATION_PRODUCT	Bactigras + Dermacyn	Patient will receive standard dressing product (bactigras + dermacyn) for the management of wound. The product will be changed everyday. Wound condition will be monitored from T0 - T6 on alternate day basis.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-06-30
• Completion: 2026-08-30
• First posted: 2025-03-13
• Last updated: 2025-03-13

Locations

1 site across 1 country: Malaysia