Wound Dressing Patch with Kelulut Honey-Infused Alginate (Tri-Gnate Alginate) for Effective Wound Care Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tri-Gnate Alginate Dressing, Dressing product from Manuka honey, Bactigras + Dermacyn.
- Who it may be relevant to
- Registry conditions: Diabetic Foot Ulcers. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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. - 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. - 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.
Primary outcome measures
- Wound Size Reduction [Time frame: Day1 - Day 14]
- Time to healing [Time frame: Day1 - Day 14]
- Patient reported pain [Time frame: Day1 - Day 14]
Secondary outcome measures (2)
- Fasting blood sugar (FBS) [Time frame: Day1 - Day 14]
- Complete blood counts (CBC) [Time frame: Day1 - Day 14]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- patient in critical state.
- patient in confuse state.
- patient do not understand Malay or English.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Malaysia · 1 center
- IIUM Medical Centre — Kuantan
Identifiers
NCT: NCT06873646 · Tri-Gnate Study