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

Universiti Sains Malaysia76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus Wound Heal Diabetes Honey

Interventions

Stingless bee honey ( Kelulut honey)OTHER

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.

Gel dressingOTHER

Smith-Nephew's Intrasite gel

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.