Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Latency time after occlusive loading
研究概览
简要总结
The purpose of this pilot study is to compare the dynamic response of microcirculation in the skin on the bottom of the big toe after applying controlled plantar stress in 25 diabetic subjects with a history of foot ulcer and 25 age-matched healthy controls to better understand the role of local hypoxia in neuropathic foot ulceration in subjects with diabetes.
The investigators hypothesize that if they apply a gait simulating load to the plantar foot and measure microvascular function, diabetic individuals will demonstrate an increased delay in reestablishing microvascular flow compared to healthy individuals.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between ages 40 and 75
- •history of diabetic neuropathic plantar ulcer (test subjects)
- •no history of diabetes (control subjects)
- •no peripheral sensory neuropathy (control subjects)
排除标准
- •amputation or surgery on right Great Toe
结局指标
主要结局
Latency time after occlusive loading
时间窗: approximately 2.75 minutes after start of collection protocol
The time between removal of occluding pressure and the initiation of the post-occlusive hyperemic response as measured by laser Doppler.
次要结局
- Response time to baseline(2.75 seconds after start of collection protocol)
- Response time to Maximum Flow(At least 2.75 seconds after the start of collection protocol.)