The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation

Study Overview
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Brief Summary
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There has been no study yet on the effect of stingless bee honey (Kelulut honey) produced by Melipolini sp. in diabetic wound healing in Malaysia. Kelulut honey, apart from possessing similar pro-healing properties with other honey, is also found to have a better antioxidant capacity, anti-inflammatory, and free radical scavenging activity than Tualang honey. These effects are due to the much higher content of phenolic and flavonoid substances in Kelulut honey, the key bioactive factors promoting wound healing and preventing oxidative stress-related injury. Australian researchers have also recently discovered a novel source of the rare disaccharide trehalose in stingless bee's honey, which is highly anti-diabetic and antioxidating. This study aims to investigate the efficacy of honey against gel dressing for wound bed preparation among diabetic patients.

Official Title
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The Effectiveness of Stingless Bee Honey (Kelulut Honey) Dressing Versus Conventional Gel Dressing for Wound Bed Preparation in Diabetic Patients With Cavity Wounds: A Randomised Controlled Trial

Conditions
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Diabetes Mellitus, Wound Heal, Diabetes, Honey

Intervention / Treatment
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* Other: Stingless bee honey ( Kelulut honey)
* Other: Gel dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female Aged between 18-70 years old Patient with full thickness cavity wound Controlled diabetes mellitus (defined as: fasting blood glucose (FBG) < 10 mmol/L upon selection) Exclusion Criteria: Severely contaminated wound/infected Patient with history of allergy to honey or stingless bee product Patients who are immunocompromised or on chronic steroid use ( defined as use of steroid for more than 2 weeks) Pregnancy End stage renal failure (ESRF) patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Honey dressing group<br>A thin layer of honey will be applied to the wounds | Other: Stingless bee honey ( Kelulut honey)<br>* The honey will be acquired from Brainey Sdn Bhd, a company that provides stingless bee honey certified with Good Manufacturing Practice (GMP), ISO 22000, and Halal. As the honey used is not medical-grade honey, sterilization with 25kGy gamma-ray irradiation will be done for safety purposes to eradicate any potential life-threatening infection such as spores from Clostridium botulinum.<br>|
| Active Comparator: Gel dressing group<br>A thin layer of gel will be applied to the wounds | Other: Gel dressing<br>* Smith-Nephew's Intrasite gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of granulation tissue | This will be calculated based on the surface area of granulation tissue traced and marked on the Opsite Flexigrid by indelible fine tip marker. The amount of small squares will calculated and this will represent the surface area. The change between baseline and at day 30 will be recorded as percentage. | 30 days | 
| Wound size reduction | This will be calculated based on the surface area of the whole wound traced and marked on the Opsite Flexigrid by indelible fine tip marker. The amount of small squares will calculated and this will represent the surface area. The change between baseline and at day 30 will be recorded as percentage. | 30 days |