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

NCT06873646 | Not Yet Recruiting Early Phase 1

• 1 other identifier: Tri-Gnate Study
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Wound Size Reduction

  Wound size reduction will be measured and jot down into data collection document. The wound condition will be measured 7 times at T0 (baseline) until T6. The wound assessment camera software will be used to measure the size of the wound (in cm2). The measurement will be carried out every alternate day. The mean score reduction of wound size (in cm2) will be used to monitor the wound condition.

  Day1 - Day 14

• Time to healing

  Time to healing will be measured based on the progress of the wound healing according to the mean of days taken. The healing progress will be monitored T0 as baseline until T6 at Day 14.

  Day1 - Day 14

• Patient reported pain

  The patient reported pain will be measured by using numerical scale from 0 (no pain) to 10 (severe pain). The pain will be assessed before the changes of new dressing done. The pain will be monitored from baseline (T0) until Day 14 (T6). Mean score of pain will be used to describe the pain present.

  Day1 - Day 14

Secondary Outcomes (2)

• Fasting blood sugar (FBS)

  Day1 - Day 14

• Complete blood counts (CBC)

  Day1 - Day 14

Study Arms (3)

Tri-Gnate Alginate Dressing

EXPERIMENTAL

Combination Product: Tri-Gnate Alginate Dressing

Dressing product from Manuka honey

ACTIVE COMPARATOR

Combination Product: Dressing product from Manuka honey

Bactigras + Dermcyn

PLACEBO COMPARATOR

Combination Product: Bactigras + Dermacyn

Interventions

Tri-Gnate Alginate Dressing COMBINATION_PRODUCT

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.

Tri-Gnate Alginate Dressing

Dressing product from Manuka honey COMBINATION_PRODUCT

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.

Dressing product from Manuka honey

Bactigras + Dermacyn COMBINATION_PRODUCT

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.

Bactigras + Dermcyn

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above.
• present with sloughly diabetes-based foot ulcer
• Has diabetic foot ulcers more than 2 weeks, less than 1 year.
• HbA1c reading than 9.0
• Ankle-brachial index pressure (ABPI) should \> 0.8
• No more than 1 diabetic foot ulcer per foot.
• no known allergy to honey of bee products
• keen on both honey and maggot debridement therapy (MDT)
• DFU classification: Wagner Grade 2, 3
• Amputation possibly deferred

You may not qualify if:

• patient in critical state.
• patient in confuse state.
• patient do not understand Malay or English.

Sponsors & Collaborators

• Mohd Khairul Zul Hasymi Firdaus: lead
• Ministry of Higher Education, Malaysia: collaborator

Study Sites (1)

IIUM Medical Centre

Kuantan, Pahang, 25200, Malaysia

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

dermacyn

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Mohd Khairul Zul Hasymi Firdaus

CONTACT

+60199086225; mkhairulzh@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 13, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

MY (1)