Abstract
The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) Diabetic Foot Consortium (DFC) was established in September
2018 by the NIDDK to build an organization to facilitate the highest
quality of clinical research on diabetic foot ulcers (DFUs) that will
answer clinically significant questions to improve DFU healing and
prevent amputations. The initial focus of the DFC is to develop and
validate biomarkers for DFUs that can be used in clinical care and
research. The DFC consists of a data coordinating center (DCC) for
operational oversight and statistical analysis, clinical sites for
participant recruitment and evaluation, and biomarker analysis units
(BAUs). The DFC is currently studying biomarkers to predict wound
healing and recurrence and is collecting biosamples for future studies
through a biorepository. The DFC plans to address the challenges of
recruitment and eligibility criteria for DFU clinical trials by taking
an approach of “No DFU Patient Goes Unstudied.” In this platform
approach, clinical history, DFU outcome, wound imaging, and biologic
measurements from a large number of patients will be captured and the
in-depth longitudinal data set will be analyzed to develop a
computational-based DFU risk factor profile to facilitate
scientifically sound clinical trial design. The DFC will expand its
platform to include studies of the role of social determinants of
health, such as food insecurity, housing instability, limited health
literacy, and poor social support. The DFC is starting partnerships
with the broad group of stakeholders in the wound care community.