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

Mohd Khairul Zul Hasymi Firdaus

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Diabetic Foot Ulcers

Treatments: Combination Product: Tri-Gnate Alginate Dressing; Combination Product: Bactigras + Dermacyn; Combination Product: Dressing product from Manuka honey

Study type: Interventional

Funder types: Other

Identifiers

NCT06873646

Tri-Gnate Study

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 3 patient groups, including a placebo group

Tri-Gnate Alginate Dressing

Experimental group

Treatment:

Combination Product: Tri-Gnate Alginate Dressing

Dressing product from Manuka honey

Active Comparator group

Treatment:

Combination Product: Dressing product from Manuka honey

Bactigras + Dermcyn

Placebo Comparator group

Treatment:

Combination Product: Bactigras + Dermacyn