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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Leonardo H Dalcheco Messias, PhD
- 전화번호: +5519998118989
- 이메일: leonardo.messias@usf.edu.br
연구 연락처 백업
- 이름: Leonardo H Dalcheco Messias, PhD
- 전화번호: 19998118989
- 이메일: leonardo.messias@usf.edu.br
연구 장소
-
-
São Paulo
-
Bragança Paulista, São Paulo, 브라질, 12916900
- Leonardo H Dalcheco Messias
-
연락하다:
- Leonardo Dalcheco Messias
- 전화번호: 19998118989
- 이메일: leonardo.messias@usf.edu.br
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clonogenic capacity of calcaneal bone marrow mesenchymal stem cells (CFU-F)
기간: Up to 14 days after bone marrow aspirate collection.
|
Number of colony-forming unit fibroblasts (CFU-F) per milliliter of calcaneal bone marrow aspirate, quantified in primary culture under standardized conditions.
|
Up to 14 days after bone marrow aspirate collection.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Osteogenic and adipogenic differentiation of mesenchymal stem cells
기간: Up to 28 days after bone marrow aspirate collection.
|
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.
|
Up to 28 days after bone marrow aspirate collection.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Vanessa Bertolucci, PhD Candidate, Universidade Sao Francisco
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- USF-IQF-BMA-DFU-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .