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Abstract
Introduction We assessed the impact of a diabetic foot ulcer prevention program incorporating once-daily foot temperature monitoring on hospitalizations, emergency department and outpatient visits, and rates of diabetic foot ulcer recurrence and lower extremity amputations for patients with recently healed foot ulcers.
Research design and methods In this retrospective analysis of real-world data, we enrolled 80 participants with a healed diabetic foot ulcer in a year-long foot ulcer recurrence prevention program. Four outpatient centers within a large integrated healthcare system in the USA contributed to enrollment. We evaluated diabetic foot-related outcomes and associated resource utilization for participants during three periods: the 2 years before the program, the year during the program, and after the program ended. We reported unadjusted resource utilization rates during the program and the periods before and after it. We then adjusted rates of outcomes in each phase using an interrupted time series approach, explicitly controlling for overall trends in resource utilization and recurrence during the three periods.
Results Our unadjusted data showed high initial rates of resource utilization and recurrence before enrollment in the program, followed by lower rates during the program, and higher rates of resource utilization and similar rates of recurrence in the period following the end of the program. The adjusted data showed lower rates of hospitalizations (relative risk reduction (RRR)=0.52; number needed to treat (NNT)=3.4), lower extremity amputations (RRR=0.71; NNT=6.4), and outpatient visits (RRR=0.26; absolute risk reduction (ARR)=3.5) during the program. We also found lower rates of foot ulcer recurrence during the program in the adjusted data, particularly for wounds with infection or greater than superficial depth (RRR=0.91; NNT=4.4).
Conclusions We observed lower rates of healthcare resource utilization for high-risk participants during enrollment in a diabetic foot prevention program incorporating once-daily foot temperature monitoring.
Trial registration number NCT04345016.
- diabetic foot
- preventive medicine
- health care costs
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Footnotes
Contributors ALI: study concept and design, clinical supervision, patient care, patient recruitment, acquisition of data, interpretation of results, and preparation of the manuscript. TDS: clinical supervision, patient care, patient recruitment, and acquisition of data. MLM and DJS: clinical supervision, patient care and patient recruitment. EAW and JLC: clinical supervision, patient care, and patient recruitment. ESW and HH: acquisition of data, analysis of data, interpretation of results, and preparation of the manuscript. BJP and DRL: study concept and design, analysis of data, interpretation of results, and preparation of the manuscript. JDB: study concept and design, and preparation of the manuscript. NJN: study concept and design, acquisition of data, and preparation of the manuscript. SJS: preparation of the manuscript. JLL: study concept and design. MAH: study concept and design and preparation of the manuscript.
Funding The resources for clinical management of this study were provided by Kaiser Permanente Mid-Atlantic States. Podimetrics Inc provided the study devices and funding to support the data analysis.
Competing interests JDB, BJP, DRL, SJS, and NJN are employees and shareholders of Podimetrics Inc, which manufactures the study device. All other authors report no real or potential conflicts of interest.
Patient consent for publication Obtained.
Ethics approval The study was reviewed by and obtained ethics approval from the Kaiser Permanente Mid-Atlantic States Institutional Review Board (MA-16–134).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request to the corresponding author for research purposes only contingent upon approval by Kaiser Permanente Mid-Atlantic Permanente Research Institute.