Randomized, Controlled Study of Nanocrystalline Silver, Manuka Honey and Conventional Dressing in Healing Diabetic Foot Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 主要终点
- Number of Participants With Complete Healing of Ulcer During the Observation Period
研究概览
简要总结
The purpose of this study is to determine whether nanocrystalline silver dressing, manuka honey dressing and conventional dressing are effective in the treatment of diabetic foot ulcer.
详细描述
Patient flow The target subjects were screened in the orthopedic department of two regional hospitals and one general outpatient clinic (GOPD). Those eligible potential subjects were recruited after they discharged from hospital according to the selection criteria. All the subjects were referred and intervened in an orthopedic nurse clinic a regional hospital. The subjects were randomized into three groups through a fixed block of 10 by online software. A sequence of assignment was generated and put into a sealed envelope by a research assistant. The investigator did not involve in randomization process and allocation sequence. The subjects were enrolled and allocated to different treatment arms according to the allocation sequence.
Data collection Outcome assessor blinding was employed in this study. A research assistant was responsible for measuring the wound size and taking clinical photo. In every clinical visit, the research assistant waited outside the clinic until the removal and proper cleansing of the wound by the first author so that she unaware of the topical treatment option. The subjects would be discontinued follow up when the wound was completely healed or till the end of 12-week study period.
Intervention All participants attended the nurse clinic for follow-up by the first author (nurse consultant) weekly in the first four week and then biweekly till 12 weeks of follow up period. They were nine clinical attendances totally. At each visit, sharp debridement for the non-viable tissue and stimulation of the vascularity on the avascular tissue were performed if needed by the first author. Then, he applied the topical dressing according to randomization sequence.
Statistical analysis All the analysis will be carried out according to the intention-to-treat principle. SPSS Statistics for Mac version 22 (SPSS Inc, Chicago, Illinois) was used for data analysis. Comparison would be made among groups by Fisher's exact test for nominal data and Kruskal-Wallis test for ordinal and scale data. The complete ulcer healing was compared among groups by Kaplan-Meier estimates. General estimating equation (GEE) was used to compare the ulcer size reduction rate, the wound fluid concentration of matrix metalloproteinase -9 (MMP9), tumor necrosis factor alpha (TNF-α) and interleukin-1 alpha (IL-1α) among groups. Statistical significance was set at p < 0.05 for all tests.
Sample size calculation
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of type 2 diabetes mellitus and
- •Age 40 or above with foot ulcer and
- •Ulcer with size equals or larger than 1 cm in diameter and
- •Ulcer located at or below malleolar region of foot and
- •Superficial ulcer, ulcer penetrates to tendon or capsule and
- •Ulcer without infection, mild and moderate infection and
- •Subject with no foreseeable surgery within 12-week study period
排除标准
- •HbA1c level ≥ 10% or
- •Severe ischemia with ankle-brachial index (ABI) ≤ 0.4 or
- •Ulcer deep into bone and joint or
- •Osteomyelitis or
- •Severe ulcer infection or
- •Known allergy to manuka honey/ nanocrystalline silver or
- •Known case of venous ulcer or varicose vein or
- •Known case of benign or malignant tumor or
- •Known to have any auto-immune disease or
- •A condition requiring medication that affects the immune response or
- •Participation in other experimental treatment studies or
- •Pregnancy
研究组 & 干预措施
Acticoat absorbent
Apply Acticoat absorbent onto the ulcer
干预措施: Acticoat absorbent (Device)
Honey gel sheet
Apply Honey gel sheet onto the ulcer
干预措施: Honey gel sheet (Device)
Jelonet
Apply Jelonet onto the ulcer
干预措施: Jelonet (Device)
结局指标
主要结局
Number of Participants With Complete Healing of Ulcer During the Observation Period
时间窗: 12 weeks
The number of participants have absence of a visible wound achieved by complete epithelialization
次要结局
- Change in Ulcer Size(12 weeks)
- the Change in Concentration of Matrix Metalloproteinases-9 (MMP-9) Level Inside Wound Fluid at Week 1 and Week 4(Week 1, Week 4)
- the Change in Concentration of Tumor Necrosis Factor Alpha (TNF-α) Level Inside Wound Fluid at Week 1 and Week 4(Week 1, Week 4)
- the Change in Concentration of Interleukin-1 Alpha (IL-1α) Level Inside Wound Fluid at Week 1 and Week 4(Week 1, Week 4)
研究者
Tsang Ka Kit
Nurse consultant
Queen Elizabeth Hospital, Hong Kong