NCT07802106Recruiting
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
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 30 Aug 2026
- Start date
- 21 Oct 2026
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Universidade Sao Francisco
- Diseases
- Type 2 diabetes
- NCT number
- NCT07802106
What you commit to
- Study type: Observational
- Planned participants: 40
- From 21 Oct 2026 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of high-dose systemic corticosteroids or other immunosuppressive drugs.
Other illness
- Active systemic infection or sepsis at the time of enrollment.
- End-stage renal disease requiring dialysis.
- 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.
Other
- Critical limb ischemia without revascularization options or hemodynamic instability.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leonardo H Dalcheco Messias Coordinator of this site? Confirm its status | Bragança Paulista | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.