Blood tests may reveal hidden healing power of bone marrow stem cells
NCT ID NCT07802106
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
Researchers are testing whether standard blood tests can indicate the quality of stem cells taken from the heel bone during foot or ankle surgery. The study includes adults aged 40 to 80, some with type 2 diabetes and diabetic foot ulcers. Before surgery, participants give blood samples; during surgery, a small amount of bone marrow is collected. Scientists then measure how well the stem cells grow and develop, and compare that with blood test results. The goal is to see if a simple blood test could help predict healing potential, though this study will not change individual treatment decisions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- No intervention; observational study collecting blood samples and bone marrow aspirate during surgery
- What this could lead to
- If routine blood tests can indicate stem cell quality, doctors might better predict healing potential in patients with diabetic foot ulcers, possibly guiding future treatments.
- What could go wrong
- This is a small, exploratory study. The link between blood markers and stem cell function may not be strong or may not apply to broader populations.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Leonardo H Dalcheco Messias
Bragança Paulista, São Paulo, 12916900, Brazil
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