A Real World, Observational Registry of Diabetic Foot Ulcers and Quality of Care in Clinical Practice
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic Foot Ulcer Outcome
- Sponsor
- U.S. Wound Registry
- Enrollment
- 10000
- Locations
- 1
- Primary Endpoint
- Wound healing
- Status
- Recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients with diabetic foot ulcers seen by the practitioner
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Wound healing
Time Frame: 6 months
wound closure
Death
Time Frame: 6 months
death without wound closure
major amputation
Time Frame: 6 months
above the knee, below the knee
minor amputation with preservation of ambulation
Time Frame: 6 months
toe amputation, transmetatarsal
Secondary Outcomes
- Patient Quality of life(12 weeks)
- Patient Reported Outcome(12 months)