Diabetes, Diabetes Mellitus, Honey, Wound Heal
Conditions
Brief summary
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.
Interventions
OTHERStingless bee honey ( Kelulut honey)
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.
OTHERGel dressing
Smith-Nephew's Intrasite gel
Sponsors
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Size of granulation tissue | 30 days | 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. |
| Wound size reduction | 30 days | 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. |
Countries
Malaysia
Contacts
Primary ContactMohamad Aizat Rosli, MB ChB
Outcome results
None listed