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

Not Applicable

• Conditions: Diabetes; Honey; Diabetes Mellitus; Wound Heal
• Interventions: Other: Stingless bee honey ( Kelulut honey); Other: Gel dressing

• Registration Number: NCT04849143
• Lead Sponsor: Universiti Sains Malaysia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-19
• Study Start: 2021-09-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-10
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Honey dressing group	Stingless bee honey ( Kelulut honey)	A thin layer of honey will be applied to the wounds
Gel dressing group	Gel dressing	A thin layer of gel will be applied to the wounds

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital Universiti Sains Malaysia; 🇲🇾 Kota Bharu, Kelantan, Malaysia