Observational studyActa diabetologica2026
Long-term outcomes of autologous cell therapy in patients with ischaemic diabetic foot ulcers and no-option chronic limb threatening ischaemia.
Observational study in Acta diabetologica, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
10 authors.
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Abstract
aimPatients with ischaemic diabetic foot ulcers (DFUs) and no-option chronic limb-threatening ischaemia (CLTI) are reported to have a high risk of major amputation and mortality. Peripheral blood mononuclear cell (PB-MNCs) therapy has emerged as a promising adjunctive strategy, but long-term data remain limited. The study aimed to evaluate the long-term outcomes of PB-MNC therapy in patients with DFUs and NO-CLTI.
methodsThis prospective, single-centre, observational, controlled study included patients with ischaemic DFUs and no-option CLTI enrolled between January 2017 and September 2023. No-option CLTI was defined by a technical failure of lower limb revascularization with the absence of any below-the-ankle vessel and/or indirect revascularization with TcPO₂ values < 30 mmHg in the wound angiosome area. Patients were divided into two groups: those receiving PB-MNCs therapy plus standard of care (SoC) and those treated only with SOC based on conventional guidelines. PB-MNCs were administered by intramuscular injections along the anatomical area of the wound-related artery (2 or 3 cycles, 21-42 days apart). At 24 months of follow-up, outcomes assessed were healing, major amputation, and mortality. In the PB-MNC group, hospital readmission for recurrent CLTI requiring repeat revascularization was also recorded.
resultsOverall, 78 patients were included: 48 in the PB-MNCs group and 30 in the conventional therapy group. The mean age was 73.7 years, 84.6% were male, and most had type 2 diabetes (92.3%). At the baseline assessment, 71.8% of DFUs were infected, 83.3% were > 5 cm², and 88.5% had gangrene. At 24 months, the PB-MNCs group showed a higher rate of healing (60.4 vs. 20%, p < 0.0001), lower rate of major amputation (12.5 vs. 26.7%, p = 0.0004), and mortality (27.1 vs. 46.7%, p = 0.0002) than the control group. CLTI recurrence requiring readmission occurred in 3/48 (6.2%) among patients in the PB-MNC group.
conclusionsIn patients with ischaemic DFUs and NO-CLTI, adjunctive PB-MNCs therapy was associated with better long-term outcomes in comparison to conventional therapy.
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