[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Universidade Sao Francisco\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":5},"100654660","systemic-biochemical-signature-and-functional-quality-index-of-calcaneal-bone-marrow-aspirate-in-adults-undergoing-foot-or-ankle-surgery-100654660",false,"NCT07802106","Systemic Biochemical Signature and Functional Quality Index of Calcaneal Bone Marrow Aspirate in Adults Undergoing Foot or Ankle Surgery","Systemic Biochemical Signature in Adults Undergoing Foot or Ankle Surgery: Integrating Routine Laboratory Markers to Assess the Functional Quality of Calcaneal Bone Marrow Aspirate Mesenchymal Stem Cells in a Prospective Cohort","IQF-BMA","Inclusion Criteria\n\n* Age 40 to 80 years.\n* Scheduled for clinically indicated foot or ankle surgery at the participating university hospital.\n* Ability to understand the study procedures and provide written informed consent.\n* Willingness to provide preoperative blood samples and intraoperative calcaneal bone marrow aspirate according to the study protocol.\n* 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.\n\nExclusion Criteria\n\n* Critical limb ischemia without revascularization options or hemodynamic instability.\n* Active systemic infection or sepsis at the time of enrollment.\n* End-stage renal disease requiring dialysis.\n* Current use of high-dose systemic corticosteroids or other immunosuppressive drugs.\n* Current or recent malignancy within the last 5 years, except adequately treated non-melanoma skin cancer.\n* Significant cognitive impairment or psychiatric condition that, in the opinion of the investigator, precludes informed consent or adherence to study procedures.\n* Pregnancy or breastfeeding.",true,"ALL","40 Years","80 Years",{"count":22,"type":23},40,"ESTIMATED","OBSERVATIONAL","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.\n\nBefore 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.\n\nA 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.",[27,28,29,30],"Diabetic Foot Ulcer","Wound Healing","Foot Ulcer Due to Type 2 Diabetes Mellitus","Diabetes Mellitus Type 2",[32,33,34,35,36,37,38,39,40,41],"Diabetic foot ulcer","Type 2 diabetes","Calcaneal bone marrow aspirate","Mesenchymal stem cells","Bone marrow aspirate concentrate","Predictive index","Biomarkers","Inflammation","Mineral-bone metabolism","Regenerative medicine","NOT_YET_RECRUITING","2026-08-30",{"date":45,"type":46},"2026-09-03","ACTUAL",{"date":48,"type":23},"2026-09-20",{"date":50,"type":23},"2029-06",{"name":52,"class":53},"Universidade Sao Francisco","OTHER",""]