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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
Improved outcomes in patients with diabetic foot ulcers despite of differences in baseline characteristics
Afram Akturk1, Jaap J van Netten1,2,3, Marloes Vermeer4
1Department of Surgery, Ziekenhuisgroep Twente (ZGT), Almelo and Hengelo, The Netherlands.
Abstract:
The incidence of diabetes is increasing worldwide with concomitant raising number of patients with diabetic foot disease. Diabetic foot disease treatment has received more attention in the past decades, culminating in the creation of multidisciplinary outpatient clinics, but at the same time, complexity of patients seems to have increased. The aim of this article is to study differences in patient characteristics and outcomes (ulcer healing and ulcer-free survival days) in patients with a diabetic foot ulcer in two prospective cohorts with 15 years in between. Prospective cohort study of all patients in one diabetic foot centre of expertise in 2003-2004 and 2014-2018. Clinical outcomes were determined after a follow-up period of 12 months. Outcomes were differences in baseline characteristics and comorbidities, and differences in ulcer-related outcomes between both cohorts. We included all consecutive diabetic foot ulcer patients from our centre for the period 2003-2004 (n = 79) and 2014-2018 (n = 271). Age (67.0 ± 14.3 vs. 71.6 ± 11.5, p = 0.003) and prevalence of end-stage renal disease (1.3% vs. 7.7%, p = 0.036) were significantly higher in the more recent population. The more recent population had higher healing rate (53.2% vs. 76.4%, p < 0.001), higher median ulcer-free survival days once an ulcer had healed [173 days (IQR 85.3-295.5) vs. 257.0 (IQR 157.0-318.0), p = 0.026], and fewer minor amputations (20.3% vs. 8.1%, p = 0.002). People with diabetic foot ulcers treated in 2014-2018 were older and more frequently diagnosed with ESRD, compared to this population in 2003-2004, while other characteristics were similar; ulcer-related outcomes were better.
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