Sterile Wound Care Liquid Dressing in Treatment of Diabetic Ulcer in Necrosis Stable Stage: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 主要终点
- 2-week reduction rate of wound area
研究概览
简要总结
This study aimed to investigate methods for promoting infection control, reducing tissue edema, and preventing excessive spread in diabetes foot ulcers in the necrosis stable stage. Additionally, it sought to explore potential indications for the use of aseptic wound care liquid dressings in these ulcers, with the goal of obtaining evidence-based medical data on their clinical efficacy.
Participants will be assigned with a 1:1 ratio into intervention group and control group.
Participants in the intervention group will be irrigated with sterile liquid dressing for each wound treatment on the basis of clinical standard treatment protocols for 2 weeks, until the end of the 2-week observation period. Participants in the control group will be irrigated with normal saline for each wound treatment for 2 weeks on the basis of the clinical standard diagnosis and treatment plan, until the end of the 2-week observation period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, respiratory failure, renal failure etc., which have not been corrected.
- •Poor glycemic control; fasting blood glucose >15mmol/L; glycosylated hemoglobin >12%.
- •Active bleeding within the wound that prevents implementation of standard basic treatment protocols.
- •Serum albumin <20g/L; hemoglobin <60g/L; platelets <50×10^9/L
- •Advanced malignant tumor patients
- •Autoimmune disease activity period
- •History of allergy to aseptic wound care liquid dressing
- •Patient unable to cooperate or has mental disorders
- •Pregnant and lactating women
- •Eye injuries and natural cavities such as ear canal, nasal cavity or abdominal cavity
- •Skin tumors
- •Active skin diseases
- •According to the researcher's judgment, patients who clearly have factors affecting wound healing that cannot be removed are not suitable for this study or cannot comply with the requirements of this study
排除标准
- 未提供
结局指标
主要结局
2-week reduction rate of wound area
时间窗: 2-week
次要结局
- 2-week wound healing rate(2-week)
研究者
Long Zhang
Professor
Peking University Third Hospital