Wound Dressing Patch with Kelulut Honey-Infused Alginate (Tri-Gnate Alginate) for Effective Wound Care Management
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Wound Size Reduction
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •patient in critical state.
- •patient in confuse state.
- •patient do not understand Malay or English.
结局指标
主要结局
Wound Size Reduction
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Fasting blood sugar (FBS)(Day1 - Day 14)
- Complete blood counts (CBC)(Day1 - Day 14)
研究者
Mohd Khairul Zul Hasymi Firdaus
Principal Investigator
Prince of Songkla University