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Clinical Trials/NCT02813161
NCT02813161
Recruiting
Not Applicable

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

U.S. Wound Registry1 site in 1 country10,000 target enrollmentFebruary 2015

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
February 2025
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
U.S. Wound Registry
Responsible Party
Sponsor

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)

Study Sites (1)

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