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

Обзор

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.

Вмешательства

• Комбинированный продукт Tri-Gnate Alginate Dressing
  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.
• Комбинированный продукт Dressing product from Manuka honey
  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.
• Комбинированный продукт Bactigras + Dermacyn
  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.

Первичные конечные точки

• Wound Size Reduction [Срок оценки: Day1 - Day 14]
• Time to healing [Срок оценки: Day1 - Day 14]
• Patient reported pain [Срок оценки: Day1 - Day 14]

Вторичные конечные точки (2)

• Fasting blood sugar (FBS) [Срок оценки: Day1 - Day 14]
• Complete blood counts (CBC) [Срок оценки: Day1 - Day 14]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Малайзия · 1 центр

• IIUM Medical Centre — Kuantan

Идентификаторы

NCT: NCT06873646 · Tri-Gnate Study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗