The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation
Primary Purpose
Diabetes Mellitus, Wound Heal, Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Stingless bee honey ( Kelulut honey)
Gel dressing
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Hospital Universiti Sains MalaysiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Honey dressing group
Gel dressing group
Arm Description
A thin layer of honey will be applied to the wounds
A thin layer of gel will be applied to the wounds
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04849143
First Posted
April 12, 2021
Last Updated
August 9, 2022
Sponsor
Universiti Sains Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT04849143
Brief Title
The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Wound Heal, Diabetes, Honey
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Honey dressing group
Arm Type
Experimental
Arm Description
A thin layer of honey will be applied to the wounds
Arm Title
Gel dressing group
Arm Type
Active Comparator
Arm Description
A thin layer of gel will be applied to the wounds
Intervention Type
Other
Intervention Name(s)
Stingless bee honey ( Kelulut honey)
Intervention Description
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
Intervention Name(s)
Gel dressing
Intervention Description
Smith-Nephew's Intrasite gel
Primary Outcome Measure Information:
Title
Size of granulation tissue
Description
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.
Time Frame
30 days
Title
Wound size reduction
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamad Aizat Rosli, MB ChB
Phone
60175123400
Email
aizat_rosli@yahoo.com.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Aizat Rosli, MB ChB
Organizational Affiliation
Universiti Sains Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universiti Sains Malaysia
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad Aizat Rosli, MB ChB
Phone
60175123400
Email
aizat_rosli@yahoo.com.my
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation
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