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

Study acronym: IQF-BMA
StatusNot Yet Recruiting
PhaseNot specified
Started2026-09-20
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07802106
Lead Sponsor Universidade Sao Francisco
Conditions Diabetic Foot Ulcer, Wound Healing, Foot Ulcer Due to Type 2 Diabetes Mellitus, Diabetes Mellitus Type 2
Enrollment 40 participants
Start Date 2026-09-20
Primary Completion 2028-07 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-03