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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Foot Ulcers
• Intervention / Treatment: Combination product: Tri-Gnate Alginate Dressing; Combination product: Dressing product from Manuka honey; Combination product: Bactigras + Dermacyn

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Mohd Khairul Zul Hasymi Firdaus; Phone Number: +6095707293 +60199086225; Email: mkhairulzh@gmail.com

Study Locations

• Malaysia
  • Pahang
    • Kuantan, Pahang, Malaysia, 25200
      • IIUM Medical Centre
      • Contact: Mohd Khairul Zul Hasymi Firdaus; Phone Number: +60199086225; Email: mkhairulzh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tri-Gnate Alginate Dressing	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.
Active Comparator: Dressing product from Manuka honey	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.
Placebo Comparator: Bactigras + Dermcyn	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting blood sugar (FBS)	A 2-3 ml of blood will be extracted from the patient. The blood will be sent to laboratory for FBS testing. The FBS value should be within 4.4 to 7.0 mmol/L. The mean value of FBS will used to monitored the blood sugar control within the patient. Higher value of FBS showed that patient has no control of the sugar. FBS will be measured on the similar day of the changing of the dressing (T0 - T6).	Day1 - Day 14
Complete blood counts (CBC)	A 2-3 ml of blood will be extracted from the patient. The blood will be sent to laboratory for CBC testing. In the CBC testing there are few components that really important and relevant to this study which are WBC, Neutrophil, lymphocyte, monocyte, eosinophil and basophil. The CBC value should be as follow: White blood cell (WBC), normal range (x10^9/L) is 2.79 - 8.09, Neutrophil (x10^9/L) is 0.91-4.61, lymphocyte (x10^9/L) is 1.12 - 3.15, monocytes (x10^9/L) is 0.23 - 0.72, eosinophil (x10^9/L) is 0.03 - 0.37 and basophil (x10^9/L) is 0.002 - 0.058. Higher counts of the stated components than normal range showed that the patient is possibly having infection. CBC will be measured on the similar day of the changing of the dressing (T0 - T6).	Day1 - Day 14

Collaborators and Investigators

• Sponsor: Mohd Khairul Zul Hasymi Firdaus
• Collaborators: Ministry of Higher Education, Malaysia

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: Tri-Gnate Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD might not be shared since we are required to not disclose any patient's data by our ethical committee clearance.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No