Findings from Regenstrief Institute’s Chronic Wound Registry may help clinicians and patients make informed decisions and improve outcomes
Chronic wounds affect thousands of patients each year and can lead to serious complications, including amputation and death. The Regenstrief Institute Chronic Wound Registry, a statewide database that collects real-world clinical data from hospitals and outpatient clinics across Indiana, allows researchers to identify patients at highest risk and generate insights that could help clinicians intervene earlier, improve care and help patients make more informed decisions.
Researchers from Regenstrief, the Indiana University School of Medicine, the University of Utah and other collaborating institutions analyzed data from 52,916 Indiana patients diagnosed with lower extremity chronic wounds between 2011 and 2021. The data, drawn from the Regenstrief Chronic Wound Registry and the Indiana Network for Patient Care (INPC), were used to model how these wounds progress over time.
Using a multistate model, the study tracked patient transitions from initial diagnosis to minor amputation, major amputation and death. Within three years of wound diagnosis, pooled mortality rates were more than 10 percent after initial diagnosis, approximately 13 percent after minor amputation and 19 percent after major amputation.
The model revealed several key clinical associations. Diabetic foot ulcers were linked to an increased risk of minor amputation, while venous ulcers were associated with lower risks of amputation and death. Pressure ulcers carried a higher risk of death but a lower risk of minor amputation. A history of osteomyelitis was associated with higher amputation risk but lower death risk before major amputation, and sepsis increased the likelihood of death before major amputation.
“The Chronic Wound Registry allows us to take a broad, real-world view of wound care and understand how different types of wounds and complications affect outcomes,” said study senior author Titus Schleyer, DMD, MBA, PhD, a Regenstrief research scientist and IU School of Medicine faculty member.
“This work shows how real-world data from multiple healthcare organizations can be used to understand who is at risk for serious outcomes,” said study lead author Joshua Choi, M.D., M.S., a researcher at the University of Utah and former Regenstrief Clinical Informatics fellow. “Ultimately, we hope this model can support clinicians in making earlier, more proactive decisions to prevent complications.”
The Regenstrief Chronic Wound Registry integrates data from the INPC, which includes health records from more than 18,000 outpatient clinics and more than 90 percent of hospitals in Indiana. It provides one of the largest and most comprehensive real-world datasets for studying wound care, enabling new insights into disease progression, infection history and treatment outcomes.
Researchers plan to expand the registry to include additional data on wound characteristics, microbiology, therapies, socioeconomic conditions and causes of mortality. Future efforts may use machine learning to extract richer information from clinician notes.
By linking data across health systems, the Regenstrief Chronic Wound Registry provides a powerful foundation for advancing research and improving care for people living with chronic wounds.
The paper, “Multistate Model of Chronic Wounds, Amputations, and Mortality,” is published in the peer-reviewed journal Annals of Surgery.
This study was supported by an Advances in Medicine award from Cook Medical, LLC, along with institutional, federal and fellowship funding from Indiana University, Indiana University Health, the Indiana Clinical and Translational Sciences Institute (National Institutes of Health /National Center for Advancing Translational Sciences grant UL1 TR002529), the University of Utah School of Medicine and the University of Pittsburgh.
Authors and affiliations, as listed in the publication
Choi, Joshua S. MD, MS*, †,‡; Kumar, Manoj PhD§,∥; Wilson, Andrew R. PhD, MStat¶,#; Mathew-Steiner, Shomita S. PhD§; Singh, Kanhaiya PhD§,††; Margolis, David J. MD, PhD§,; Schleyer, Titus K. L. DMD, MBA, PhD‡,‡‡; Sen, Chandan K. PhD§,**,§§
*Department of Biomedical Informatics, Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, UT, United States
†Department of Internal Medicine, Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, UT, United States
‡Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, IN, United States
McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, PA, United States
∥Centre for Economic Studies and Planning, Jawaharlal Nehru University, New Delhi, India
¶Parexel International (MA) Corporation, Durham, NC, United States
#Department of Family and Preventive Medicine, Spencer Fox Eccles School of Medicine, University of Utah, Salt Lake City, UT, United States
**Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States
††Department of Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA, United States
‡‡Department of Medicine, School of Medicine, Indiana University, Indianapolis, IN, United States
§Indiana Center for Regenerative Medicine, Indiana University, Indianapolis, IN, United States
The Indiana Network for Patient Care
The Indiana Network for Patient Care, created at Regenstrief Institute in 1994 and operated by the Indiana Health Information Exchange since 2004, is one of the largest and most mature clinical data repositories in the U.S., providing considerable depth and breadth as the basis for a health information exchange.
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