- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02813161
The Diabetic Foot Ulcer Registry (DFUR)
April 30, 2018 updated by: U.S. Wound Registry
A Real World, Observational Registry of Diabetic Foot Ulcers and Quality of Care in Clinical Practice
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.
Study Overview
Status
Recruiting
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.
Study Type
Observational
Enrollment (Anticipated)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Monica Weir, MBA, CCRP
- Phone Number: (800) 603-7896
- Email: monica.weir@uswoundregistry.com
Study Contact Backup
- Name: Caroline E Fife, MD
- Phone Number: (800) 603-7896
- Email: cfife@uswoundregistry.com
Study Locations
-
-
Texas
-
The Woodlands, Texas, United States, 77384
- Recruiting
- CHI St. Luke's The Woodlands
-
Contact:
- Sherrill White Wolfe
- Phone Number: 936-266-2150
- Email: swhitewolfe@stlukeshealth.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Prospectively followed diabetic foot ulcers in the practice of clinicians submitting data to the registry
Description
Inclusion Criteria:
- All patients with diabetic foot ulcers seen by the practitioner
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wound healing
Time Frame: 6 months
|
wound closure
|
6 months
|
major amputation
Time Frame: 6 months
|
above the knee, below the knee
|
6 months
|
minor amputation with preservation of ambulation
Time Frame: 6 months
|
toe amputation, transmetatarsal
|
6 months
|
Death
Time Frame: 6 months
|
death without wound closure
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Quality of life
Time Frame: 12 weeks
|
W-QoL score
|
12 weeks
|
Patient Reported Outcome
Time Frame: 12 months
|
using patient reported outcome quality measure
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2015
Primary Completion (Anticipated)
January 1, 2025
Study Completion (Anticipated)
February 1, 2025
Study Registration Dates
First Submitted
June 10, 2016
First Submitted That Met QC Criteria
June 21, 2016
First Posted (Estimate)
June 24, 2016
Study Record Updates
Last Update Posted (Actual)
May 3, 2018
Last Update Submitted That Met QC Criteria
April 30, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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