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

NCT ID: NCT06873646

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Foot Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Tri-Gnate Alginate Dressing

Group Type EXPERIMENTAL

Tri-Gnate Alginate Dressing

Intervention Type 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.

Dressing product from Manuka honey

Group Type ACTIVE_COMPARATOR

Dressing product from Manuka honey

Intervention Type 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.

Bactigras + Dermcyn

Group Type PLACEBO_COMPARATOR

Bactigras + Dermacyn

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Higher Education, Malaysia

OTHER

Sponsor Role collaborator

Mohd Khairul Zul Hasymi Firdaus

OTHER

Sponsor Role lead

Responsible Party

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Mohd Khairul Zul Hasymi Firdaus

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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IIUM Medical Centre

Kuantan, Pahang, Malaysia

Site Status

Countries

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Malaysia

Central Contacts

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Mohd Khairul Zul Hasymi Firdaus

Role: CONTACT

+60199086225 ext. +6095707293

Facility Contacts

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Mohd Khairul Zul Hasymi Firdaus

Role: primary

+60199086225

Other Identifiers

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Tri-Gnate Study

Identifier Type: -

Identifier Source: org_study_id

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