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Search / Trial NCT06873646

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

Launched by MOHD KHAIRUL ZUL HASYMI FIRDAUS · Mar 7, 2025

Trial Information

Current as of April 29, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new wound dressing patch called Tri-Gnate Alginate, which contains a special type of honey called Kelulut honey. The goal is to see if this honey-infused dressing helps heal diabetic foot ulcers more effectively than traditional treatments, which include standard dressings and another type of honey called Manuka honey. In total, 110 patients with diabetic foot ulcers will be involved in the study. Participants will be randomly assigned to one of three groups: one will receive the Tri-Gnate Alginate dressing, another will use the Manuka honey patch, and the third will get standard care. Before applying these dressings, all patients will undergo a procedure known as Maggot Debridement Therapy to clean their wounds.

To be eligible for the trial, participants should be at least 18 years old, have a specific type of diabetic foot ulcer that has been present for more than two weeks but less than a year, and should not have any known allergies to honey. They also need to be comfortable with both honey and the use of maggots to help with wound cleaning. Throughout the study, patients will have their wounds checked seven times over a series of days to track how well they are healing. It’s important to note that this trial is not yet recruiting participants, but it aims to provide valuable insights into better wound care for people with diabetes.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age 18 and above.
  • 2. present with sloughly diabetes-based foot ulcer
  • 3. Has diabetic foot ulcers more than 2 weeks, less than 1 year.
  • 4. HbA1c reading than 9.0
  • 5. Ankle-brachial index pressure (ABPI) should \> 0.8
  • 6. No more than 1 diabetic foot ulcer per foot.
  • 7. no known allergy to honey of bee products
  • 8. keen on both honey and maggot debridement therapy (MDT)
  • 9. DFU classification: Wagner Grade 2, 3
  • 10. Amputation possibly deferred
  • Exclusion Criteria:
  • 1. patient in critical state.
  • 2. patient in confuse state.
  • 3. patient do not understand Malay or English.

About Mohd Khairul Zul Hasymi Firdaus

Mohd Khairul Zul Hasymi Firdaus is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With expertise in coordinating and overseeing clinical studies, he focuses on ensuring compliance with regulatory standards while fostering collaboration among research teams. His leadership is characterized by a meticulous approach to trial management, promoting innovation and ethical practices in the development of new therapeutic options. Passionate about enhancing healthcare through rigorous scientific inquiry, he actively contributes to the growth of the clinical research landscape.

Locations

Kuantan, Pahang, Malaysia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported