The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 278
- 试验地点
- 4
- 主要终点
- Presence/absence of the same S. aureus genetic profile in the nose and on the foot lesion.
研究概览
简要总结
The presence of S aureus in the nasal passages of diabetic patients may be a risk factor for diabetic foot lesion infections. Our aim is to compare the genetic profiles of S aureus strains found in the noses and on the foot lesions of diabetic patients. The investigators are also studying the virulence of these strains, the prevalance of S aureus at either site, and whether or not the quantity of S aureus found in the nose affects the risk for infection in foot lesions. The investigators also use this study to test the sensitivity and specificity of the GeneXpert system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Type 1 or 2 diabetic patients
- •Patients consulting or hospitalized in the Diabetology departments of one of the participating centers
- •Grade 2-4 ulcer on the foot or ankle (both primo and recurrent events are acceptable)
排除标准
- •Patient refuses to participate
- •Pregnant, parturient or breastfeeding women
- •Patient does not have diabetic foot or arteritic
- •Diabetic ulcer is located elsewhere than the foot or ankle
- •The ulcer is non-swabbable
- •Patient does not have social-security coverage
- •Patient is under any type of guardianship
研究组 & 干预措施
All patients
All patients
干预措施: Genetic profiling of bacterial cultures (Biological)
结局指标
主要结局
Presence/absence of the same S. aureus genetic profile in the nose and on the foot lesion.
时间窗: 3 hours
Presence/absence of the same S. aureus genetic profile in the nose and on the foot lesion. Genetic profiles do not change with time. This is a transversal, pinpoint measure.
次要结局
未报告次要终点