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Updated: Oct 5, 2025

Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers
Published on: March 3, 2023
Higher rates of all-cause mortality and resource utilization during episodes-of-care for diabetic foot ulceration
Brian J Petersen1, Walter T Linde-Zwirble2, Tze-Woei Tan3
1Podimetrics, Inc., 100 Dover St, Somerville, MA 02144, USA.
Aims:
Our primary objective was to determine whether all-cause rates of mortality and resource utilization were higher during periods of diabetic foot ulceration. In support of this objective, a secondary objective was to develop and validate an episode-of-care model for diabetic foot ulceration.
Methods:
We evaluated data from the Medicare Limited Data Set between 2013 and 2019. We defined episodes-of-care by clustering diabetic foot ulcer related claims such that the longest time interval between consecutive claims in any cluster did not exceed a duration which was adjusted to match two aspects of foot ulcer episodes that are well-established in the literature: healing rate at 12 weeks, and reulceration rate following healing. We compared rates of outcomes during periods of ulceration to rates immediately following healing to estimate incidence ratios.
Results:
The episode-of-care model had a minimum mean relative error of 4.2% in the two validation criteria using a clustering duration of seven weeks. Compared to periods after healing, all-cause inpatient admissions were 2.8 times more likely during foot ulcer episodes and death was 1.5 times more likely.
Conclusions:
A newly-validated episode-of-care model for diabetic foot ulcers suggests an underappreciated association between foot ulcer episodes and all-cause resource utilization and mortality.
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