NCT02445170撤回不适用
Heath-related Quality of Life of Diabetic Transmetatarsal Amputees and Below-knee Prosthetic Users
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Health-related quality of life measured by the HRQoL score
研究概览
简要总结
The present study assesses the health-related quality of life of diabetic transmetatarstal and below-knee prosthetic user. The study design is cross-sectional with a retrospective review of patient hospital records and an assessment with patient-reported outcome measure.
详细描述
The present study aims to recruit 100 diabetic transmetatarsal and below-knee prosthetic user to assess the health-related quality of life (HRQoL) between these two patient groups. The 15D HRQoL instrument is applied. An additional comparison with the age-standardized Finnish general population will be performed.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
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 with diabetes
- •Transmetatarsal amputation
- •Below-knee prosthetic user
- •2-5 years from surgery
排除标准
- •No diabetes
- •Other than transmetatarsal or below-knee amputation
- •Below-knee amputation but not a below-knee prosthetic user
- •Less than 2 years from the amputation
- •Over 5 years from amputation
结局指标
主要结局
Health-related quality of life measured by the HRQoL score
时间窗: 2-5 years
次要结局
- The 15D health-related quality of life instrument(2-5 years)
研究者
Jussi Repo
Researcher
Helsinki University Central Hospital
研究点 (1)
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