Pilot Usability Study to Set Up and Use the Feetsee™ Foot Monitoring Device in Adults With Diabetes
Single-center, prospective, minimal-risk, non-experimental usability study assessing the setup and use of the FDA-registered (Class I medical device; 510(k)-exempt) Feetsee™ home foot-monitoring system by adults with diabetes in their home environment over 8 weeks.
This study in non clinical, observational pilot usability study conducted under FDA Human Factors and Usability Engineering guidance (2016).
研究概览
详细说明
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Helena Grinberg, PhD
- 电话号码：+31615636666
- 邮箱：lenagrin@gmail.com
研究联系人备份
- 姓名：Rytis Zajančkauskas, MD
- 电话号码：rytis@diabetis.lt
学习地点
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Texas
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San Antonio、Texas、美国、78229
- UT Health San Antonio
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接触：
- Nick Lucio
- 电话号码：210-567-5142
- 邮箱：luciond@uthscsa.edu
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首席研究员：
- Lawrence A. Lavery, MD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
This study will enroll adult participants with diabetes who are at risk for diabetic foot complications and who are able to use a smartphone-based home monitoring system. Participants represent the intended user population of the Feetsee™ Foot Monitoring System.
Participants will be recruited from diabetes, endocrinology, and podiatry clinics at UT Health San Antonio and affiliated University Health clinical sites under the supervision of the Principal Investigator.
描述
Inclusion Criteria:
- Males and females aged 18 years or older
- Clinical diagnosis of Type 1 or Type 2 diabetes
- At least one palpable foot pulse per feet
- Possess basic ability to use a smartphone or tablet
- Have no prior experience with the Feetsee™ system
- Be willing and able to provide informed consent
Exclusion Criteria:
- Active foot ulceration at enrollment
- Active Charcot neuro-osteoarthropathy
- Severe vascular disease (complete absence of foot pulses)
- Amputation of more than three toes
- Active malignancy or immunosuppressive condition
- Cognitive or physical impairments preventing proper device usage
- Concurrent participation in another investigational study with contraindicated procedures
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Type 1 or Type 2 diabetes, recruited from outpatient clinics
Approximately 20 adults (≥18 years) with Type 1 or Type 2 diabetes, recruited from outpatient clinics at UT Health San Antonio
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: after initial training, participants set up and use the Feetsee foot-monitoring system in their own homes, following the US IFU and in-app instructions.
Data will be collected via paper/electronic CRFs, patient questionnaires, and Feetsee device/app usage logs (exported to REDCap and secure sponsor databases).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Usability of the Feetsee Foot Monitoring System
大体时间：8 weeks
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• To evaluate the usability of the Feetsee Foot Monitoring System by both patients and healthcare providers when they use only the provided labeling, Quick Start Guide, Instructions for Use (IFU), and in-app instructions
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8 weeks
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合作者和调查者
赞助
调查人员
- 首席研究员：Lawrence A. Lavery, MD、The University of Texas Health Science Center at San Antonio
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.