NCT03964571已完成不适用
Human and Bacterial Protease Activity As Prognostic Tool of Foot Infections in Diabetic Patients
Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2019年10月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 4
- 主要终点
- Reduction in size of wound
研究概览
简要总结
This study will establish whether human and bacterial protease activity can aid therapeutic decision-making, including targeted treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •The patient has been informed about the study objectives and purpose and their rights as a patient
- •The patient is being treated in the Diabetes and Infectious Disease Department
- •The patient has a chronic foot and/or heel wound classified as Grade 1-3 according to the Infectious Diseases Society of America.
排除标准
- •The subject is participating in another category I interventional study, or has participated in another category I interventional trial in the previous 3 months, or is in a period of exclusion determined by a previous study
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •The patient is pregnant or breastfeeding
- •The patient has chronic foot and/or heel wound classified as Grade 4 according to the Infectious Diseases Society of America
- •Patient with critical ischemia defined by PSGo <50 mmHg or PSCh <70 mmHg
研究组 & 干预措施
Diabetic foot patients
Experimental
干预措施: WOUNDCHEK (Diagnostic Test)
结局指标
主要结局
Reduction in size of wound
时间窗: From Day 0 to week 4
% change in surface area of wound; traced on OpSite Flexigrid ® film
次要结局
- Reduction in size of wound(From Day 0 to Week 2)
- Presence of elevated protease activity in foot wound(Day 28)
- Presence of bacterial protease activity in foot wound(Day 28)
- Presence of pathogenic bacteria in wound(Day 28)
- Clinical exam of wound(Day 0)
- Presence of elevated protease activity in foot wound(Day 0)
- Presence of pathogenic bacteria in wound(Day 0)
- Presence of pathogenic bacteria in wound(Day 14)
- Presence of elevated protease activity in foot wound(Day 14)
- Presence of bacterial protease activity in foot wound(Day 0, 14 and 28)
- Presence of bacterial protease activity in foot wound(Day 14)
研究者
研究点 (4)
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