Diabetic Foot UlcersEarly Phase 1NCT06873646
Wound Dressing Patch with Kelulut Honey-Infused Alginate (Tri-Gnate Alginate) for Effective Wound Care Management
A Early Phase 1 study testing Tri-Gnate Alginate Dressing, Dressing product from Manuka honey and Bactigras + Dermacyn in people with Diabetic Foot Ulcers, run by Mohd Khairul Zul Hasymi Firdaus at 1 site in Malaysia.
Trial summary
The main aim of this study to effectiveness of dressing patch with Kelulut honey (Tri-Gnate Alginate) in promoting wound healing compared to conventional treatments (standard wound dressing + bactigras) and other types of medicinal honey based product (Manuka honey product). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Tri-Gnate Alginate Dressing, Dressing product from Manuka honey and Bactigras + Dermacyn
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Nov 2025to 30 Aug 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and above.
- present with sloughly diabetes-based foot ulcer
- Has diabetic foot ulcers more than 2 weeks, less than 1 year.
- HbA1c reading than 9.0
- Ankle-brachial index pressure (ABPI) should > 0.8
- No more than 1 diabetic foot ulcer per foot.
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- no known allergy to honey of bee products
- keen on both honey and maggot debridement therapy (MDT)
- DFU classification: Wagner Grade 2, 3
- Amputation possibly deferred
Who cannot join
- patient in critical state.
- patient in confuse state.
- patient do not understand Malay or English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
IIUM Medical Centre
Kuantan, Pahang, 25200
Mohd Khairul Zul Hasymi Firdaus, +60199086225, mkhairulzh@gmail.com
About this study
The main aim of this study to effectiveness of dressing patch with Kelulut honey (Tri-Gnate Alginate) in promoting wound healing compared to conventional treatments (standard wound dressing + bactigras) and other types of medicinal honey based product (Manuka honey product). Tri-Gnate alginate is a product produced by researcher team which upgraded from raw honey into a dressing patch. 110 patients with diabetic foot ulcers is expected to enrol in this program. The patients will be assigned randomly into 3 groups namely as Group 1 - patient that will receive Tri-Gnate alginate product in their dressing, Group 2 - patient will receive Manuka honey patch product and group 3 - the patient will receive standard care (bactigras dressing + dermacyn). Prior to the applying of these dressing treatment, all the patient will receive Maggot Debridement Therapy (MDT) to ensure the wound is clean. Patient's wound condition will be monitored 7 times (T0 - T6) on alternate day basis for healing improvement.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Tri-Gnate Alginate Dressing, Dressing product from Manuka honey, Bactigras + Dermacyn
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tri-Gnate Alginate DressingCombination product
Patient will receive dressing product (Tri-Gnate Alginate) for the management of wound. The product will be put on every alternate day. Wound condition will be monitored from T0 - T6.
Dressing product from Manuka honeyCombination product
Patient will receive other type of dressing product (Manuka honey product) for the management of wound. The product will be put on every alternate day. Wound condition will be monitored from T0 - T6.
Bactigras + DermacynCombination product
Patient will receive standard dressing product (bactigras + dermacyn) for the management of wound. The product will be changed everyday. Wound condition will be monitored from T0 - T6 on alternate day basis.
| Study group | Role | What they receive |
|---|---|---|
| Tri-Gnate Alginate Dressing | Experimental | Not described Receives: Combination Product: Tri-Gnate Alginate Dressing |
| Dressing product from Manuka honey | Active comparator | Not described Receives: Combination Product: Dressing product from Manuka honey |
| Bactigras + Dermcyn | Placebo comparator | Not described Receives: Combination Product: Bactigras + Dermacyn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Size Reduction
Wound size reduction will be measured and jot down into data collection document. The wound condition will be measured 7 times at T0 (baseline) until T6. The wound assessment camera software will be used to measure the size of the wound (in cm2). The measurement will be carried out every alternate day. The mean score reduction of wound size (in cm2) will be used to monitor the wound condition.
Measured: Day1 - Day 14
Time to healing
Time to healing will be measured based on the progress of the wound healing according to the mean of days taken. The healing progress will be monitored T0 as baseline until T6 at Day 14.
Measured: Day1 - Day 14
Patient reported pain
The patient reported pain will be measured by using numerical scale from 0 (no pain) to 10 (severe pain). The pain will be assessed before the changes of new dressing done. The pain will be monitored from baseline (T0) until Day 14 (T6). Mean score of pain will be used to describe the pain present.
Measured: Day1 - Day 14
Secondary outcomes (2)
Fasting blood sugar (FBS)
A 2-3 ml of blood will be extracted from the patient. The blood will be sent to laboratory for FBS testing. The FBS value should be within 4.4 to 7.0 mmol/L. The mean value of FBS will used to monitored the blood sugar control within the patient. Higher value of FBS showed that patient has no control of the sugar. FBS will be measured on the similar day of the changing of the dressing (T0 - T6).
Measured: Day1 - Day 14
Complete blood counts (CBC)
A 2-3 ml of blood will be extracted from the patient. The blood will be sent to laboratory for CBC testing. In the CBC testing there are few components that really important and relevant to this study which are WBC, Neutrophil, lymphocyte, monocyte, eosinophil and basophil. The CBC value should be as follow: White blood cell (WBC), normal range (x10^9/L) is 2.79 - 8.09, Neutrophil (x10^9/L) is 0.91-4.61, lymphocyte (x10^9/L) is 1.12 - 3.15, monocytes (x10^9/L) is 0.23 - 0.72, eosinophil (x10^9/L) is 0.03 - 0.37 and basophil (x10^9/L) is 0.002 - 0.058. Higher counts of the stated components than normal range showed that the patient is possibly having infection. CBC will be measured on the similar day of the changing of the dressing (T0 - T6).
Measured: Day1 - Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Nov 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohd Khairul Zul Hasymi Firdaus
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Higher Education, Malaysia
- Responsible party
- Sponsor-investigator, Mohd Khairul Zul Hasymi Firdaus, Prince of Songkla University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873646
- Sponsor's protocol ID
- Tri-Gnate Study
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD might not be shared since we are required to not disclose any patient's data by our ethical committee clearance.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Dressing Patch with Kelulut Honey-Infused Alginate (Tri-Gnate Alginate) for Effective Wound Care Management
- ClinicalTrials.gov ID
- NCT06873646
- Acronym / sponsor ID
- Tri-Gnate Study
- Conditions
- Diabetic Foot Ulcers
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Mohd Khairul Zul Hasymi FirdausUniversity, hospital or other
- Collaborators
- Ministry of Higher Education, Malaysia
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study to effectiveness of dressing patch with Kelulut honey (Tri-Gnate Alginate) in promoting wound healing compared to conventional treatments (standard wound dressing + bactigras) and other types of medicinal honey based product (Manuka honey product). Tri-Gnate alginate is a product produced by researcher team which upgraded from raw honey into a dressing patch. 110 patients with diabetic foot ulcers is expected to enrol in this program. The patients will be assigned randomly into 3 groups namely as Group 1 - patient that will receive Tri-Gnate alginate product in their dressing, Group 2 - patient will receive Manuka honey patch product and group 3 - the patient will receive standard care (bactigras dressing + dermacyn). Prior to the applying of these dressing treatment, all the patient will receive Maggot Debridement Therapy (MDT) to ensure the wound is clean. Patient's wound condition will be monitored 7 times (T0 - T6) on alternate day basis for healing improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tri-Gnate Alginate Dressing | Experimental | Combination Product: Tri-Gnate Alginate Dressing |
| Dressing product from Manuka honey | Active comparator | Combination Product: Dressing product from Manuka honey |
| Bactigras + Dermcyn | Placebo comparator | Combination Product: Bactigras + Dermacyn |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 and above.
- present with sloughly diabetes-based foot ulcer
- Has diabetic foot ulcers more than 2 weeks, less than 1 year.
- HbA1c reading than 9.0
- Ankle-brachial index pressure (ABPI) should > 0.8
Key exclusion criteria (3 listed)
- patient in critical state.
- patient in confuse state.
- patient do not understand Malay or English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tri-Gnate Alginate DressingPatient will receive dressing product (Tri-Gnate Alginate) for the management of wound. The product will be put on every alternate day. Wound condition will be monitored from T0 - T6. | Combination product | Tri-Gnate Alginate Dressing |
| Dressing product from Manuka honeyPatient will receive other type of dressing product (Manuka honey product) for the management of wound. The product will be put on every alternate day. Wound condition will be monitored from T0 - T6. | Combination product | Dressing product from Manuka honey |
| Bactigras + DermacynPatient will receive standard dressing product (bactigras + dermacyn) for the management of wound. The product will be changed everyday. Wound condition will be monitored from T0 - T6 on alternate day basis. | Combination product | Bactigras + Dermcyn |
Primary outcome
Wound Size Reduction
Time frame: Day1 - Day 14
Wound size reduction will be measured and jot down into data collection document. The wound condition will be measured 7 times at T0 (baseline) until T6. The wound assessment camera software will be used to measure the size of the wound (in cm2). The measurement will be carried out every alternate day. The mean score reduction of wound size (in cm2) will be used to monitor the wound condition.
Time to healing
Time frame: Day1 - Day 14
Time to healing will be measured based on the progress of the wound healing according to the mean of days taken. The healing progress will be monitored T0 as baseline until T6 at Day 14.
Patient reported pain
Time frame: Day1 - Day 14
The patient reported pain will be measured by using numerical scale from 0 (no pain) to 10 (severe pain). The pain will be assessed before the changes of new dressing done. The pain will be monitored from baseline (T0) until Day 14 (T6). Mean score of pain will be used to describe the pain present.
2 secondary outcomes
Fasting blood sugar (FBS)
Time frame: Day1 - Day 14
Complete blood counts (CBC)
Time frame: Day1 - Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: Undecided. IPD might not be shared since we are required to not disclose any patient's data by our ethical committee clearance.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tri-Gnate Alginate Dressing, Dressing product from Manuka honey and Bactigras + Dermacyn in people with Diabetic Foot Ulcers, run by Mohd Khairul Zul Hasymi Firdaus at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohd Khairul Zul Hasymi Firdaus (+60199086225 ext. +6095707293, mkhairulzh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Size Reduction (time frame: Day1 - Day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.