跳至主要内容
临床试验/NCT02813161
NCT02813161招募中不适用

A Real World, Observational Registry of Diabetic Foot Ulcers and Quality of Care in Clinical Practice

U.S. Wound Registry1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
1
主要终点
Wound healing

研究概览

简要总结

This is an observational, longitudinal real world registry of diabetic foot ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR.

详细描述

This is an observational, longitudinal real world registry of diabetic foot ulcers created from electronic health record data obtained in the course of clinical care. Data from certified electronic health records transmit data as part of the requirement to share data with a specialty registry under Objective 10 of Meaningful Use of an EHR. No secondary data entry are required and all data are obtained via structured language from data entered in the EHR. Data from quality measures designed as electronic clinical quality measures (eCQMs) standardize the quality of care provided to patients and their clinical outcomes which are risk stratified using the Wound Healing Index (WHI). The eCQMs enable standardized data collection and the ability to transmit data electronically obviates the possibility of transcription errors. National benchmarking is possible since data are available from thousands of participants across the USA. While an independent IRB oversees this project, the data are collected for the purpose of measuring and improving the quality of care delivered to diabetic patients with foot ulcers and understanding their outcomes in relation to level of risk. Quality performance is reported as part of PQRS. These functions are exempt from the requirements of informed consent.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients with diabetic foot ulcers seen by the practitioner

排除标准

  • 未提供

结局指标

主要结局

Wound healing

时间窗: 6 months

wound closure

Death

时间窗: 6 months

death without wound closure

major amputation

时间窗: 6 months

above the knee, below the knee

minor amputation with preservation of ambulation

时间窗: 6 months

toe amputation, transmetatarsal

次要结局

  • Patient Quality of life(12 weeks)
  • Patient Reported Outcome(12 months)

研究者

发起方
U.S. Wound Registry
申办方类型
Other
责任方
Sponsor

研究点 (1)

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