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Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers
Published on: March 3, 2023
Ulcer Recurrence Impairs Outcomes of Patients with Diabetic Foot
Martina Salvi1,2, Marco Meloni1,2, Federico Rolando Bonanni1,2
1Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
None:
Background and AimsThe aim of the study was to evaluate the prevalence of recurrent diabetic foot ulcers (DFUs) requiring hospital admission and to assess their impact on mid-term clinical outcomes.Methods and ResultsIt is a single-center retrospective observational study including a population of patients with DFUs requiring hospitalization managed between January and September 2024 in a tertiary level diabetic foot service. All patients were treated by a local multidisciplinary team in accordance with international guidelines. The study cohort consisted of two groups: patients with a recurrent DFU and those with a first-time DFU. After discharge, all patients were regularly followed as outpatients. After six months of follow-up, the following outcomes were evaluated and compared between groups: healing, major amputation, and mortality. Overall, 205 patients were included (31.7% recurrent DFU vs 68.3% first-time DFU). The mean age was 68.9 ± 12.3 years, the majority had type 2 diabetes (93.4%) with a mean diabetes duration of 20.9 ± 12.6 years; 155 (75.6%) patients presented with ischemic DFUs, and 158 (77.1%) patients had diabetic foot infections. There were no significant differences between the two groups at the assessment, except for the higher rate of ischemic heart disease in recurrent patients when compared to not recurrent (50.8 vs 30.7%, P = .006).ConclusionSix-months outcomes (recurrent DFU vs first-time DFU) were as follows: wound healing (47.7 vs 62.8%, P = .04), major amputation (4.6 vs 5%, P = .2), and mortality (12.3 vs 4.3% P = .03), respectively. Multivariate logistic regression analysis showed that ulcer recurrence was an independent predictor of non-healing, while it did not significantly influence the risk of major amputation or mortality.
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