A Real World, Observational Registry of Diabetic Foot Ulcers and Quality of Care in Clinical Practice
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.
Condition:
Diabetic Foot Ulcer Outcome
Treatment:
cellular and tissue based therapy
Start Date:
February 2015
Sponsor:
U.S. Wound Registry
For More Information:
https://clinicaltrials.gov/show/NCT02813161