Calcaneal Bone Marrow Cells in Foot/Ankle Surgery Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this single-center prospective cohort, adults aged 40–80 having clinically indicated foot or ankle surgery will have preoperative blood tests and intraoperative collection of calcaneal bone marrow. Mesenchymal stem cells will be isolated and evaluated for clonogenic capacity, osteogenic and adipogenic differentiation, cellular senescence, and cytokine secretion to explore links with systemic biomarkers. Observational data will be recorded for participants with and without type 2 diabetes and, when present, Wagner grades 2–4 diabetic foot ulcers. The study uses standardized laboratory assays to characterize functional properties of the cells without assigning any intervention. Informed consent is required prior to procedures.

Why it matters

Who can join: the full rules

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.

Where it's running

• Leonardo H Dalcheco Messias
  Bragança Paulista, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Vanessa Bertolucci, PhD Candidate — Universidade Sao Francisco
• Study coordinator: Leonardo H Dalcheco Messias, PhD
• Email: leonardo.messias@usf.edu.br
• Phone: +5519998118989

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Single-layer placental graft plus standard care for stubborn diabetic foot ulcers

  This trial will try a single-layer placental-based graft together with usual wound care for adults whose diabetic foot ulcers did not heal after standard treatment in an earlier trial.

  Recruiting Phase 4 Applied Biologics, LLC · Hollywood, Florida · NCT07159282

• Wound matrix treatments for nonhealing diabetic foot ulcers

  This trial will test whether adding special wound matrix products to standard care helps close hard-to-heal diabetic foot ulcers in adults with type 1 or 2 diabetes within 12 weeks.

  Recruiting Phase 4 Sequence LifeScience, Inc. · Monroeville, Pennsylvania · NCT07086443

• Using stem cells from fat to treat diabetic foot ulcers

  This study is testing if using stem cells from fat, along with a special blood product, can help heal chronic foot ulcers in people with diabetes.

  Recruiting Phase 1 University of the Punjab · Lahore, Punjab Province · NCT05610865

• Proliverenol for liver fat and insulin resistance in type 2 diabetes

  This study tests whether adding Proliverenol to standard diabetes care can improve liver fat and blood sugar control in adults with type 2 diabetes.

  Recruiting Phase 2 Universitas Sriwijaya · Palembang, South Sumatera · NCT07928661

• Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes

  This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.

  Recruiting Pamukkale University · Denizli · NCT07924436

• Safety test of NNC9836-0001 in adults with overweight/obesity or type 2 diabetes

  This study tests whether the new medicine NNC9836-0001 is safe and tolerable in adults who are overweight or have type 2 diabetes, compared to placebo.

  Recruiting Phase 1 Novo Nordisk A/S · Neuss · NCT07896109

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.