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Systemic Biochemical Signature and Functional Quality Index of Calcaneal Bone Marrow Aspirate in Adults Undergoing Foot or Ankle Surgery

Recruitingn/aAges 40 Years - 80 YearsAllUniversidade Sao Francisco
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria * 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. * Participants may have comorbidities, including type 2 diabetes mellitus and, when present, active Wagner grade 2-4 diabetic foot ulcers. These clinical characteristics will be recorded for observational analyses and do not define separate study groups. Exclusion Criteria * 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. * Current or recent malignancy within the last 5 years, except adequately treated non-melanoma skin cancer. * Significant cognitive impairment or psychiatric condition that, in the opinion of the investigator, precludes informed consent or adherence to study procedures. * Pregnancy or breastfeeding.
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What it tests

  • Not listed
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Where

1 site
Leonardo H Dalcheco Messias
Bragança Paulista, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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