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
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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NOT_YET_RECRUITING
EARLY_PHASE1
110 participants
INTERVENTIONAL
2025-11-01
2026-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tri-Gnate Alginate Dressing
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.
Dressing product from Manuka honey
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.
Bactigras + Dermcyn
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
2. patient in confuse state.
3. patient do not understand Malay or English.
18 Years
65 Years
ALL
No
Sponsors
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Ministry of Higher Education, Malaysia
OTHER
Mohd Khairul Zul Hasymi Firdaus
OTHER
Responsible Party
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Mohd Khairul Zul Hasymi Firdaus
Principal Investigator
Locations
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IIUM Medical Centre
Kuantan, Pahang, Malaysia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Tri-Gnate Study
Identifier Type: -
Identifier Source: org_study_id
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