NCT03555656终止不适用
Patient Education for the Prevention of Lower Limb Ulcers in Patients With Type 2 Diabetes: Validation of an Educational Intervention Repeated Every Three Months for 2 Years.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Incidence of foot ulcers
研究概览
简要总结
Following a prior observation that a brief structured group educational intervention is effective for the prevention of diabetic foot ulcers in high-risk patients, but that the efficacy decreases over the time, this study is designed to verify the effect of a repetition of the educational intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Type 2 diabetes mellitus
- •Either diabetic neuropathy or previous foot ulcer
排除标准
- •Arteriopathy of lower limbs, with ABI<0.8 or needing revascularization
研究组 & 干预措施
Repeated educational intervention
Experimental
Repetition every 6 months of a group educational session
干预措施: Repeated intervention (Behavioral)
Control group
Active Comparator
Initial single group educational session, with no repetition
干预措施: Single session (Behavioral)
结局指标
主要结局
Incidence of foot ulcers
时间窗: 24 months
次要结局
- Incidence of foot ulcers(6 months)
- incidence of foot ulcers(12 months)
研究者
Edoardo Mannucci
Director, Diabetology
Azienda Ospedaliero-Universitaria Careggi
研究点 (1)
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