Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06873646

Wound Dressing Patch with Kelulut Honey-Infused Alginate (Tri-Gnate Alginate) for Effective Wound Care Management

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Diabetic Foot Ulcers Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

Exclusion criteria

  • patient in critical state.
  • patient in confuse state.
  • patient do not understand Malay or English.

Treatment and study plan

Tri-Gnate Alginate Dressing

Combination 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 honey

Combination 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 + Dermacyn

Combination 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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Fasting blood sugar (FBS)

    Time frame: Day1 - Day 14

    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).

  2. Complete blood counts (CBC)

    Time frame: Day1 - Day 14

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Mohd Khairul Zul Hasymi Firdaus

CONTACT

[email protected]

+60199086225 ext. +6095707293

Sponsors and collaborators

Lead sponsor

Mohd Khairul Zul Hasymi Firdaus

Other

Collaborators

  • Ministry of Higher Education, Malaysia

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.