Innovative Device for Pressure Point Identification and Vibration Perception Assessment in Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The study is expected to enhance diabetic foot
研究概览
简要总结
A novel device has been developed to improve care for
diabetic patients by identifying pressure points and monitoring
nerve function, aimed at preventing foot ulcers. The device
uses a footscan pressure mat with multiple sensors and
vibrators to assess plantar pressure and vibration perception
threshold. The mat produces a color map and pressure curves
for different foot regions, while the vibratory stimulus helps
measure nerve function. This technology significantly reduces
the risk of diabetic foot ulcers and neuropathy by addressing
high-pressure areas and monitoring nerve health.
Claims of the Invention
• A PORTABLE PRESSURE SENSING AND
VIBRATION PERCEPTION DEVICE FOR EARLY
DETECTION OF PERIPHERAL NEUROPATHY
IN DIABETES THROUGH WHICH WE CAN
IMPLEMENT EFFECTIVE
FOOTWEAR/OFFLOADING DEVICES.
• EASY ACCESIBLE,COST EFFECIENT,TIME
CONSUMING WITH ACCURATE READING
S.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •18 years or older.
- •Diagnosed with Type 1 or Type 2 diabetes mellitus.
- •Participants with or without peripheral neuropathy.
排除标准
- •History of foot or leg surgery within the last 6 months.
- •Presence of active infections or ulcers on feet.
- •Pregnant or planning to become pregnant during the study period.
- •Any severe cardiovascular, neurological, or orthopedic conditions that could affect the ability to participate.
结局指标
主要结局
The study is expected to enhance diabetic foot
时间窗: At baseline, at 4 weeks, and at 8 weeks after initial assessment.
care by accurately identifying pressure points and
时间窗: At baseline, at 4 weeks, and at 8 weeks after initial assessment.
assessing vibration perception, leading to timely
时间窗: At baseline, at 4 weeks, and at 8 weeks after initial assessment.
interventions and improved patient outcomes. Additionally, it aims to empower patients and provide
时间窗: At baseline, at 4 weeks, and at 8 weeks after initial assessment.
valuable insights for healthcare providers in managing
时间窗: At baseline, at 4 weeks, and at 8 weeks after initial assessment.
diabetic complications.
时间窗: At baseline, at 4 weeks, and at 8 weeks after initial assessment.
次要结局
- Reliability of the innovative device(Day 0 (15–30 min & within 2 h); Day 7 ±2 days.)
- Usability of the device(Immediately after assessment on Day 0.)
- Patient comfort during device assessment(Immediately after assessment on Day 0; optional safety/comfort check at 24 h ±6 h by phone.)
- Predictive ulcer risk(Month 3 ±2 weeks; Month 6 ±3 weeks; Month 12 ±4 weeks.)
研究者
Purushothaman D
Saveetha Institute of Medical and Technical Sciences