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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04849143
• Other study ID #: USM/JEPeM/21020186
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: June 2023

Study information

• Verified date: August 2022
• Source: Universiti Sains Malaysia
• Contact: Mohamad Aizat Rosli, MB ChB
• Phone: 60175123400
• Email: aizat_rosli[@]yahoo.com.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Honey
• Wound Heal
• Wounds and Injuries

Intervention

Other:
• Stingless 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.
• Gel dressing
Smith-Nephew's Intrasite gel

Locations

Country	Name	City	State
Malaysia	Hospital Universiti Sains Malaysia	Kota Bharu	Kelantan

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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