NCT02647346已完成不适用
In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 16
- 主要终点
- Occurrence of Plantar Diabetic Foot Ulcer
研究概览
简要总结
The purpose of this study is to investigate the accuracy of a Smart Foot Mat for signals associated with diabetic foot ulcers in high-risk patients.
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
- •Male/Female, 18 years or older
- •Diagnosis of type 1 or type 2 Diabetes Mellitus, controlled or uncontrolled
- •Ankle Brachial Index (ABI) >0.5
- •Patient with history of previous foot ulcer.
排除标准
- •Active Charcot foot disease
- •One or more plantar foot ulcers (UT Grade 1A-C, 2A-C & 3A-C)
- •Active Infection/Gangrene
- •Active malignancy
- •Immunosuppressive disease
- •History of alcohol or drug abuse
- •Pregnant women (verbal confirmation or confirmation obtained within current medical records)
- •Cognitive deficit
- •2+ or great lower extremity edema
- •End stage renal disease
- •History of major lower extremity amputation (below knee or above knee amputation)
- •Other issue that, at the discretion of the investigator, renders the subject ineligible for participation.
结局指标
主要结局
Occurrence of Plantar Diabetic Foot Ulcer
时间窗: Through study completion or subject withdrawal (34 weeks per-protocol)
次要结局
- Device-related Trips/Falls(Through study completion or subject withdrawal (34 weeks per-protocol))
- Subject Adherence in Daily Use of the Study Device(Through study completion or subject withdrawal (34 weeks per-protocol))
- Device-related Injuries(Through study completion or subject withdrawal (34 weeks per-protocol))
研究者
研究点 (16)
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