Systemic Biochemical Signature and Functional Quality Index of Calcaneal Bone Marrow Aspirate in Adults Undergoing Foot or Ankle Surgery (IQF-BMA)
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
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.
Visão geral do estudo
Status
Descrição detalhada
This is a single-center, observational, prospective cohort study conducted at a university hospital in Brazil. The study will enroll 40 adults aged 40 to 80 years who are undergoing clinically indicated foot or ankle surgery. Participants may present with or without comorbidities, including type 2 diabetes mellitus and, when present, active Wagner grade 2-4 diabetic foot ulcers. These clinical characteristics will be recorded as observational variables and will not define intervention assignments or separate study arms. All participants will provide written informed consent before any study procedures.
Before surgery, participants will undergo a panel of routine laboratory tests covering four domains: inflammatory burden, including complete blood count, derived inflammatory indices, and albumin; glycometabolic burden, including fasting glucose, oral glucose tolerance test when clinically feasible, HbA1c, triglycerides, and cholesterol profile; mineral-renal burden, including creatinine, urea, ionized calcium, phosphorus, magnesium, alkaline phosphatase, parathyroid hormone, and 25-OH vitamin D; and tissue-energetic damage, including lactate dehydrogenase, AST, and ALT.
During the clinically indicated orthopedic surgery, calcaneal bone marrow aspirate will be collected from the same operative field. Mesenchymal stem cells will be isolated, cultured, and evaluated using standardized functional assays, including clonogenic capacity, osteogenic differentiation, adipogenic differentiation, cellular senescence, cytokine secretion, and cellular viability.
The Functional Quality Index of Bone Marrow Aspirate (IQF-BMA) will be constructed from standardized routine laboratory variables representing inflammatory, glycometabolic, mineral-renal, and tissue-energetic domains. The primary analysis will examine the association between the IQF-BMA and the clonogenic capacity of calcaneal bone marrow mesenchymal stem cells. Secondary analyses will examine associations between laboratory markers or the composite index and other cellular functional outcomes. Results will be reported primarily as effect estimates and 95% confidence intervals to support the planning of future, larger studies.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Leonardo H Dalcheco Messias, PhD
- Número de telefone: +5519998118989
- E-mail: leonardo.messias@usf.edu.br
Estude backup de contato
- Nome: Leonardo H Dalcheco Messias, PhD
- Número de telefone: 19998118989
- E-mail: leonardo.messias@usf.edu.br
Locais de estudo
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São Paulo
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Bragança Paulista, São Paulo, Brasil, 12916900
- Leonardo H Dalcheco Messias
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Contato:
- Leonardo Dalcheco Messias
- Número de telefone: 19998118989
- E-mail: leonardo.messias@usf.edu.br
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Foot/Ankle Surgery Cohort
Adults undergoing clinically indicated foot or ankle surgery at a university hospital in Brazil, with or without comorbidities, including type 2 diabetes mellitus and, when present, active Wagner grade 2-4 diabetic foot ulcers.
Blood samples and calcaneal bone marrow aspirate will be collected for systemic laboratory tests and mesenchymal stem cell functional assays.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Clonogenic capacity of calcaneal bone marrow mesenchymal stem cells (CFU-F)
Prazo: Up to 14 days after bone marrow aspirate collection.
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Number of colony-forming unit fibroblasts (CFU-F) per milliliter of calcaneal bone marrow aspirate, quantified in primary culture under standardized conditions.
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Up to 14 days after bone marrow aspirate collection.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Osteogenic and adipogenic differentiation of mesenchymal stem cells
Prazo: Up to 28 days after bone marrow aspirate collection.
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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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Up to 28 days after bone marrow aspirate collection.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Vanessa Bertolucci, PhD Candidate, Universidade Sao Francisco
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Doenças Vasculares
- Doenças cardiovasculares
- Processos Patológicos
- Doenças Metabólicas
- Distúrbios do Metabolismo da Glicose
- Diabetes Mellitus
- Angiopatias Diabéticas
- Complicações do Diabetes
- Doenças de pele
- Úlcera de pele
- Úlcera de perna
- Neuropatias diabéticas
- Úlcera do pé
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Doenças da Pele e do Tecido Conjuntivo
- Diabetes Mellitus, Tipo 2
- Inflamação
- Pé diabético
Outros números de identificação do estudo
- USF-IQF-BMA-DFU-001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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