ClinicalTrials.gg
Status unknownNCT04849143Updated Aug 10, 2022

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

An interventional study of Stingless bee honey ( Kelulut honey) and Gel dressing in Diabetes Mellitus, Wound Heal and Diabetes, sponsored by Universiti Sains Malaysia. Status unknown at 1 site in Malaysia. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-10.

Sponsored by Universiti Sains Malaysia · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus
  • Wound Heal
  • Diabetes
  • Honey

Browse trials for

03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 76 is close to the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Universiti Sains Malaysia is the lead sponsor of 175 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    Honey dressing group

    A thin layer of honey will be applied to the wounds

    Other: Stingless bee honey ( Kelulut honey)

  • Active comparator
    Gel dressing group

    A thin layer of gel will be applied to the wounds

    Other: Gel dressing

Interventions

  • OtherStingless 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.

  • OtherGel dressing

    Smith-Nephew's Intrasite gel

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

  2. 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.

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
  • Hospital Universiti Sains Malaysia
    Kota Bharu, Kelantan 16150, Malaysia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04849143
Responsible party
Mohamad Aizat Bin Rosli (Principal Investigator, Universiti Sains Malaysia) — Principal investigator
First posted
Apr 19, 2021
Start date
Sep 1, 2021
Primary completion
Jun 2023 (estimated)
Completion
Jun 2023 (estimated)
Last update
Aug 10, 2022

Study contacts

Mohamad Aizat Rosli, MB ChB
Contact
aizat_rosli@yahoo.com.my
60175123400
Mohamad Aizat Rosli, MB ChB
principal investigator · Universiti Sains Malaysia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion