Pilot Study on the Presence of Microangiopathy in Diabetic Foot Ulcer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- presence of microangiopathy
研究概览
简要总结
The purpose of this study will be the assessment of microangiopathy determined by the increase of capillary basement membrane thickness and decrease of capillary lumen area in the foot ulcer of 30 neuropathic and 30 neuroischemic type 2 diabetic patients
详细描述
Primary endpoint of the study is to quantitatively evaluate the presence of microangiopathy as increase of capillary basement membrane thickness and decrease of capillary lumen area determined by transmission electron microscopy analysis in type 2 diabetic patients with only motor-sensory neuropathy or chronic critical ischemia affected by foot ulcer.
The following parameters will be evaluated:
- presence of capillary (n/mm2) and thrombosis (%) and correlation of this quantitative histological data with ischemic parameters (TcPO2, ankle-brachial index) and risk of diastasis
- correlation between presence of inflammatory infiltrate (leukocytes/mm2) with blood inflammatory parameters (erythrocyte sedimentation rate (ESR), C-reactive protein, alpha-2 globulin)
- rate of diastasis and/or time required for recovery associated with histopathological data
- presence of acanthosis related to clinical and demographic variables
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult type 2 diabetic patients of either gender
- •diabetes for more than 10 years
- •motor-sensory diabetic neuropathy with or without chronic critical ischemia
- •local residents
- •ulcer with surgical therapy indication of removal the 1st ray because of gangrene or osteomyelitis
排除标准
- •type 1 diabetic patients
- •diabetes for less than 10 years
- •renal replacement therapy
- •urgent surgical procedure for sepsis
- •immunosuppressive therapy
- •not local residents
- •Cancer with adverse prognosis in months, or chemotheraputic treatment
- •Ongoing or planned pregnancy
- •Lack of consent to participate to the study
结局指标
主要结局
presence of microangiopathy
时间窗: 24 hours after surgical amputation at the first ray level for treatment of foot ulcer
presence of microangiopathy as increase of capillary basement membrane thickness and decrease of capillary lumen area by transmission electron microscopy in the skin of type 2 diabetic patients with foot ulcer
次要结局
未报告次要终点