Cutaneous Microcirculation and Diabetic Foot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Cutaneous blood flow
研究概览
简要总结
15% of diabetics have a diabetic foot (DF) in their lives associated with a risk of amputation and mortality two times greater than that of a diabetic population without DF. Predicting the occurrence of an DF is limited and only the occurrence of a diabetic wound up involved assessment and treatment. Our team is behind the discovery of the Pressure-Induced Vasodilation (PIV) first observed in healthy subjects after local application of a gradual pressure on the skin leading to cutaneous vasodilation at the application of pressure. This gain in blood flow delays the onset of ischemia. However the involvement of PIV in the DF, which is also a pressure-induced skin lesion, remains to be demonstrated in diabetic subjects. The main objective of this study is to show that PIV, a functional examination of the cutaneous microcirculation we developed, is altered in the presence of DF, taking into account the influence of age and neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Men and Women
- •Presence of diabetes
- •Signed acknowledgement form
排除标准
- •No signed acknowledgement form
- •patients under 18 year-old
研究组 & 干预措施
Diabetic patients with MPP
干预措施: Lidocaine/prilocaine 1g (topical administration) (Drug)
Diabetic patients without MPP
干预措施: Lidocaine/prilocaine 1g (topical administration) (Drug)
结局指标
主要结局
Cutaneous blood flow
时间窗: Within 3 months after inclusion
次要结局
- Effect of neuropathy on PIV impairment(Within 3 months after inclusion)
