Wound EMR to Decrease Limb Amputations in Persons With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,609
- 试验地点
- 13
- 主要终点
- Lower extremity amputation secondary to diabetic foot ulcer
研究概览
简要总结
The purpose of this study is to determine whether using the OWEMR as part of the standard of care for Diabetic Foot Ulcers reduces the rate of lower limb amputations and to quantify the relationship between glycemic control and the rate of amputation secondary to chronic foot ulcers in Type II Diabetes.
详细描述
The Online Wound Electronic Medical Record (OWEMR) is a medical informatics tool that synthesizes data about complex wound problems from multiple sources and is innovative in its capability to performing these critical tasks: i) identification of the information needed to make treatment decisions at the point of care in real time ii) use intelligent search and report features to identify patients who require emergency interventions, and iii) provide evidence-based clinical decision support to clinicians. Use of the OWEMR includes digital photography as an objective measurement of wound healing rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Signed informed Consent
- •Type I or II diabetes*
- •A break in the skin on the foot ≥ 0.5cm2
- •18 yrs of age or older
- •Hemoglobin A1c value within the last 120 days
- •No use of Investigational Agents /Devices on study or within 30 days prior to enrollment
- •Subjects who will be locally available for the next 6 months
排除标准
- 未提供
研究组 & 干预措施
OWEMR
Medical centers will be randomized to use the Online Wound Electronic Medical Record to enhance care of patients with diabetic foot ulcers
干预措施: Online Wound Electronic Medical Record (Other)
Standard of Care
Medical/wound centers will be randomized to continue routine care of patients with diabetic foot ulcers
结局指标
主要结局
Lower extremity amputation secondary to diabetic foot ulcer
时间窗: 6 months
次要结局
未报告次要终点
研究者
Stephen Warren
Principal Investigator
NYU Langone Health