Thermal Screening for Early Diabetic Peripheral Neuropathy (DPN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 331
- 试验地点
- 1
- 主要终点
- Pattern of thermal recovery
研究概览
简要总结
The goal of this research is to develop better tools for diagnosing illness of the feet and legs of people who have diabetes. Investigators will use thermal videos of the foot to aid in the refinement of a system designed to detect signs of diabetic peripheral neuropathy (DPN). The team of investigators will also look at diabetic eye disease and how it might relate to diabetic foot disease.
详细描述
This study focuses on further development and testing of a microvascular functional imaging system, a computer-based system for screening thermal video images, designed to detect biomarkers of diabetic peripheral neuropathy (DPN). Additionally, severity levels of diabetic retinopathy (DR) will be compared with those of DPN.
All participants in this study will undergo foot exams, thermal imaging of the foot, and standard retinal imaging. These non-invasive assessments will be performed at an initial study visit. Some of the participants will be offered additional study visits. One of the additional visits involves a standard nerve conduction velocity assessment by a neurologist, the other involves a DPN exam by a podiatrist.
Portions of the study take place at University of New Mexico Health Sciences Center (UNM HSC). The research utilizes services of the Clinical Translational Science Center (CTSC).
The study is approved by University of New Mexico Health Sciences Center's Human Research Review Committee (HRRC), which coordinates and supports the activities of the three federally mandated Human Research Review Committees (HRRCs) responsible for reviewing and approving all human research.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be non-diabetic or diagnosed as diabetic for at least 5 years
排除标准
- •history of chemotherapy
- •surgery below the knee within the last 2 years
- •fractures below the know within the last 2 years
- •history of stroke
- •body mass index (BMI) greater than 35
- •history of heart failure
- •peacemaker or implantable cardiovascular defibrillator
- •high blood pressure (over 180/100)
- •end-stage renal (kidney) disease or renal (kidney) transplant
- •peripheral edema greater than 2+ (swelling of the feet or hands)
- •diabetic foot ulcers
- •foot sores
- •Raynaud's phenomenon
- •tobacco use within the last month.
- •treatment with glucocorticoids, including:
- •beclomethasone
- •betamethasone
- •budesonide
- •cortisone
- •dexamethasone
- •hydrocortisone
- •methylprednisolone
- •prednisolone
- •prednisone
- •triamcinolone
结局指标
主要结局
Pattern of thermal recovery
时间窗: 24 months
The thermal recovery pattern after cold provocation will be different for each group studied.
次要结局
- Correlation of DPN severity levels and DR severity levels(18 months)