Clinical Trials of Footwear in Patients With Diabetes-Study Arm 2,3
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 427
- 试验地点
- 1
研究概览
简要总结
This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of foot ulcers, and (2) Estimate costs of ulcer prevention using these strategies.
详细描述
This is a randomized clinical trial to: (1) Determine the extent to which custom made study shoes will reduce the incidence of reulceration in diabetic individuals with prior history of footulcers, and (2) Estimate costs of ulcer prevention using these strategies. Patients from the Seattle VA (n=214) and Group Health Cooperative (n=213) will be randomly assigned to one of two study arms. They are: (1) patients wearing study shoes and premolded polyurethane insoles and (2) the control group of patients wearing their own footwear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供