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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus Wound Heal Diabetes Honey

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Honey dressing group

A thin layer of honey will be applied to the wounds

Group Type EXPERIMENTAL

Stingless bee honey ( Kelulut honey)

Intervention Type 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 dressing group

A thin layer of gel will be applied to the wounds

Group Type ACTIVE_COMPARATOR

Gel dressing

Intervention Type OTHER

Smith-Nephew's Intrasite gel

Interventions

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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.

Intervention Type OTHER

Gel dressing

Smith-Nephew's Intrasite gel

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes