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

NCT04849143 | Unknown

• 1 other identifier: USM/JEPeM/21020186
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Wound Heal; Diabetes; Honey

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Honey dressing group

EXPERIMENTAL

A thin layer of honey will be applied to the wounds

Other: Stingless bee honey ( Kelulut honey)

Gel dressing group

ACTIVE COMPARATOR

A thin layer of gel will be applied to the wounds

Other: Gel dressing

Interventions

Stingless bee honey ( Kelulut honey) 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.

Honey dressing group

Gel dressing OTHER

Smith-Nephew's Intrasite gel

Gel dressing group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

aloe vera gel extract hydrogel dressing

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mohamad Aizat Rosli, MB ChB

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamad Aizat Rosli, MB ChB

CONTACT

60175123400; aizat_rosli@yahoo.com.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 19, 2021
• Study Start: September 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 10, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)