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

Universiti Sains Malaysia

Status: Enrolling

Conditions: Diabetes; Diabetes Mellitus; Honey; Wound Heal

Treatments: Other: Stingless bee honey ( Kelulut honey); Other: Gel dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT04849143

USM/JEPeM/21020186

Details and patient eligibility

About

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

Honey dressing group

Experimental group

Description:

A thin layer of honey will be applied to the wounds

Treatment:

Other: Stingless bee honey ( Kelulut honey)

Gel dressing group

Active Comparator group

Description:

A thin layer of gel will be applied to the wounds

Treatment:

Other: Gel dressing