Principle Investigator
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Blood Perfusion
研究概览
简要总结
The investigators would like to see if the combination of TENS and controlled heat in a boot increases blood flow to the foot more than baseline or heat alone in people with and without diabetes. This may help people with diabetes and a diabetic wound that will not heal.
详细描述
Procedure
- Sit comfortably in a reclining chair for 5 minutes while temperature, SPO2, and heart rate are taken, and any further questions can be answered with a pulse oximeter and temperature
a. The procedure for temperature, heart rate, and blood saturation rate will be taken using a Homedics Non-Contact Infrared Thermometer. The infrared beam will be pointed at the subject's forehead at approximately 1 foot away, and within 2 seconds, the temperature will be recorded and time-stamped.
b. Procedure for the Pulse Oximeter- A SPO2 Pulse Oximeter will be placed on the subject's foot. The SPO2 sensors are embedded in the insole. The oxygen saturation level and pulse rate will be documented. The pulse oximeter will be cleaned with isopropyl alcohol before and after each use. 2. Temperature
a. The procedure for taking Room temperature-Reading of the room temperature via the thermostat located in the lab. 3. Once the baseline temperature, SPO2, heart rate, and room temperature are documented, a PPG sensor will be located and embedded in the insole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female aged between 45-75 years old
- •Clinical diagnosis of Type I or Type II diabetes
- •Controlled diabetes mellitus (HbA1c ≤ 7%)
排除标准
- •Pregnancy
- •Current smoker
- •Diagnosed neuropathy
- •Uncontrolled hypertension (HTN)
- •Allergy to tape or electrodes
- •Diagnosis of dementia
- •History of knee joint replacement
- •Significant joint pain (e.g., back, hip, or ankle) that may limit the ability to wear a boot for 60 minutes
- •Contraindications to TENS, including:
- •Presence of pacemakers
- •Dermatological conditions
- •Abnormal sensation in the knees
- •Severe medical or neurological conditions, including:
- •Chronic obstructive pulmonary disease
- •Cardiovascular disease
- •Arteriosclerosis obliterans
- •Cerebrovascular accident
- •Lumbar disc disorders (e.g., herniation)
- •Rheumatoid arthritis
- •Fear of electrical stimulation
结局指标
主要结局
Blood Perfusion
时间窗: During 30 minutes of electrical stimulation and heat application.
Peripheral Blood Perfusion and Oxygen Saturation (SpO₂) assessed using pulse oximetry.
次要结局
未报告次要终点
研究者
Massood Atashbar
PI
Western Michigan University