NCT03213093招募中不适用
Neurovascular Cutaneous Response to Pressure and Risk of Diabetic Foot Ulcer in Patients With Type 2 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- the rate of incidence of diabetic foot ulcer
研究概览
简要总结
Diabetic foot ulcer (DFU) is a worldwide burden in the management of patients with diabetes. Peripheral neuropathy has a key role in the physiopathology of DFU. Others factors as skin vulnerability to plantar pressure, glycation of skin protein, articular rigidity, vascular component and abnormal foot plantar pressure are also important to take into account. The aim of the study is to assess prospectively different factors involved in DFU pathogenesis notably the neurovascular response to non noxious pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Age >18 years
- •Type 2 diabetic subject
- •Absence of active diabetic foot ulcer
- •Patients "Grade 0", "Grade 1", "Grade 2" or "Grade 3" of the International Working Group on Diabetic Foot Risk Classification defined by:
- •absence of alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 0"
- •alteration of perception of Monofilament 10g at the level of the plantar arch for the "grade 1"
- •alteration of perception of Monofilament 10g at the level of the plantar arch associated with foot deformity and / or an arteriopathy defined by the absence of perception of one of the two peripheral pulses for the "grade 2"
- •History of diabetic foot ulcer for the "grade 3"
- •Signature of consent to participate in the study
排除标准
- •Chronic alcoholism with usual consumption of at least 5 alcoholic drinks per day
- •Pregnancy
- •Congenital methemoglobinemia.
- •Porphyria
- •Skin injured on the tibia, whatever the lesion
- •Recent major cardiovascular history (less than 3 months)
- •Severe renal disease (serum creatinine> 300 μmol.l-1)
结局指标
主要结局
the rate of incidence of diabetic foot ulcer
时间窗: At any time during a 3 years follow-up
A diabetic foot ulcer is defined as a breakdown in the skin under malleolus
次要结局
- Neurovascular response to pressure(At the end of the 3-year follow-up)
研究者
研究点 (2)
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