NCT02168348已完成不适用
Impact of Malnutrition on the Healing of Foot Lesions in Diabetic Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Percentage of healed lesions
研究概览
简要总结
The investigators set out to determine whether malnutrition delayed healing of foot lesions in diabetic patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients who have provided oral consent
- •Patients older than 18
- •Patients with type 1 or 2 diabetes
- •Patients who can be followed-up in the context of consultations for diabetic foot at the endocrinology, diabetology and metabolic diseases unit of Dijon CHU.
- •Lesion situated on a toe or on the plantar or dorsal side of the foot
- •Lesion that has evolved for 1 to 24 months
排除标准
- •Adult under guardianship
- •Patient without national health insurance
- •Pregnant or breast-feeding women
- •Patients with progressive cancer
- •Patients with terminal renal insufficiency on dialysis
- •Patient with severe respiratory insufficiency
- •Patients with terminal heart failure
- •Patients with severe liver failure
- •Patients with immunodepriession (treatement with immunosuppressants, long-term corticotherapy, diseases leading to immunodepression)
- •Patients with nephrotic syndrome (hypoalbuminemia)
- •Patientswith a chronic inflammatory syndrome
- •Alcohol consumption greater than 4 glasses per day
- •Systemic infection uncontrolled by antibiotics
- •Infected lesion with systemic repercussions
- •Charcot foot
- •Patients taking part or who have planned to take part in another clinical trial
- •Severe disease affecting survival in the short term
- •Lesion on an amputation
- •Lesion of the ankle or leg
研究组 & 干预措施
Diabetic patients with a lesion on the foot
干预措施: biological examination at consultations at 3 and 6 months (Other)
结局指标
主要结局
Percentage of healed lesions
时间窗: After 24 weeks of follow-up
次要结局
- Number of malnourished patients according to HAS 2003 and 2007 criteria(At inclusion)
研究者
研究点 (1)
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