NCT02317835已完成1 期
An Innovative System for the Early Identification, Monitoring, Evaluation and Diagnosis of Diabetic Foot Ulcers
King's College Hospital NHS Trust6 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 6
- 主要终点
- Detection of hot spots on a foot thermal map image
研究概览
简要总结
To evaluate a recently developed non-invasive infrared thermal camera called Diabetic Foot Ulcer Prevention System (DFUPS) in a clinical setting by studying healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Aged 18 years or older
- •Has no history of diabetes
- •Has no previous history of foot ulceration
- •Has no previous history of foot surgery
- •Has palpable foot pulses on both feet (palpable posterior tibial artery pulse OR dorsalis pedis artery pulse OR both)
- •Has no history of peripheral neuropathy
- •Has no history of peripheral arterial disease
- •Must be able to provide meaningful written informed consent for the study
排除标准
- •Has active foot ulceration and infection
- •Has foot deformity which in the opinion of the Investigator, would interfere with interpreting the results of the study
- •Has any uncontrolled illness that, in the opinion of the Investigator, would interfere with interpreting the results of the study
- •Has an implantable electronic device
- •Is aged <18
结局指标
主要结局
Detection of hot spots on a foot thermal map image
时间窗: 9 months
次要结局
未报告次要终点
研究者
研究点 (6)
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