This observational prospective cohort study will evaluate whether routine blood tests are associated with the functional quality of calcaneal bone marrow aspirate mesenchymal stem cells in adults undergoing clinically indicated foot or ankle surgery at a university hospital in Brazil. Participants aged 40 to 80 years, with or without comorbidities, including type 2 diabetes mellitus and, when present, active Wagner grade 2-4 diabetic foot ulcers, will be eligible for inclusion.
Before surgery, participants will undergo routine blood tests, including complete blood count, glucose and lipid profile, mineral-renal markers, and tissue damage markers. During the clinically indicated surgery, calcaneal bone marrow aspirate will be collected from the same operative field. Mesenchymal stem cells will be isolated and evaluated in the laboratory for clonogenic capacity, osteogenic and adipogenic differentiation, cellular senescence, and secretion of inflammatory and anti-inflammatory cytokines.
A composite Functional Quality Index of Bone Marrow Aspirate (IQF-BMA) will be constructed from routine laboratory markers to characterize inflammatory, metabolic, mineral-renal, and tissue-damage burden. The primary objective is to examine the association between the IQF-BMA and mesenchymal stem cell functional outcomes, particularly clonogenic capacity. This exploratory study will not be used to guide individual treatment decisions.
Age 40 to 80 years.
Scheduled for clinically indicated foot or ankle surgery at the participating university hospital.
Ability to understand the study procedures and provide written informed consent.
Willingness to provide preoperative blood samples and intraoperative calcaneal bone marrow aspirate according to the study protocol.
Critical limb ischemia without revascularization options or hemodynamic instability.
Active systemic infection or sepsis at the time of enrollment.
End-stage renal disease requiring dialysis.
Current use of high-dose systemic corticosteroids or other immunosuppressive drugs.
Adults aged 40 to 80 years undergoing clinically indicated foot or ankle surgery at a university hospital in Brazil. Participants may have comorbidities, including type 2 diabetes mellitus and, when present, active Wagner grade 2-4 diabetic foot ulcers. All participants will undergo standardized preoperative blood collection and intraoperative calcaneal bone marrow aspirate collection for observational laboratory analyses.
Cohort
Prospective
Not listed
Clonogenic capacity of calcaneal bone marrow mesenchymal stem cells (CFU-F)
Number of colony-forming unit fibroblasts (CFU-F) per milliliter of calcaneal bone marrow aspirate, quantified in primary culture under standardized conditions.
Osteogenic and adipogenic differentiation of mesenchymal stem cells
Osteogenic and adipogenic differentiation capacity of calcaneal bone marrow mesenchymal stem cells, assessed by alkaline phosphatase activity and semi-quantitative scoring of Alizarin Red and Oil Red O staining.
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