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

NCT07802106 | Not Yet Recruiting

• 1 other identifier: USF-IQF-BMA-DFU-001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Ulcer; Wound Healing; Foot Ulcer Due to Type 2 Diabetes Mellitus; Diabetes Mellitus Type 2

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Clonogenic capacity of calcaneal bone marrow mesenchymal stem cells (CFU-F)

  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.

Secondary Outcomes (1)

• Osteogenic and adipogenic differentiation of mesenchymal stem cells

  Up to 28 days after bone marrow aspirate collection.

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 40 to 80 years undergoing clinically indicated foot or ankle surgery at a university hospital in Brazil. Participants may have comorbidities, including type 2 diabetes mellitus and, when present, active Wagner grade 2-4 diabetic foot ulcers. All participants will undergo standardized preoperative blood collection and intraoperative calcaneal bone marrow aspirate collection for observational laboratory analyses.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Sao Francisco: lead

Study Sites (1)

Leonardo H Dalcheco Messias

Bragança Paulista, São Paulo, 12916900, Brazil

Location

Related Links

• Graduate Program in Health Sciences, Universidade de São Francisco

Biospecimen

Retention: SAMPLES WITHOUT DNA

Calcaneal bone marrow aspirate collected intraoperatively during clinically indicated foot or ankle surgery will be retained for isolation and culture of mesenchymal stem cells and related functional assays. Samples will be obtained from both diabetic (type 2 diabetes mellitus with active Wagner grade 2-4 diabetic foot ulcer) and non-diabetic participants, including both biological female and male adults aged 40 to 80 years. No DNA will be extracted from these samples.

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus, Type 2; Inflammation

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vanessa Bertolucci, PhD Candidate

  Universidade Sao Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonardo H Dalcheco Messias, PhD

CONTACT

+5519998118989; leonardo.messias@usf.edu.br

Leonardo H Dalcheco Messias, PhD

CONTACT

19998118989; leonardo.messias@usf.edu.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 3, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)