Could stem cells from the placenta heal stubborn diabetic wounds?
NCT ID NCT07686094
First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time
Summary
This early-stage trial is testing whether injecting placental stem cells into and around non-healing diabetic foot ulcers is safe. The study involves 12 people with Type 2 diabetes who have a foot ulcer that has not healed for at least four weeks despite standard care. Researchers will monitor for side effects like bleeding, infection, or allergic reactions, and also track whether the wound shrinks over a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Placental stem cells
- What this could lead to
- If safe and effective, this approach could offer a new way to heal stubborn diabetic foot ulcers and reduce the risk of amputation.
- What could go wrong
- This is a very early Phase 1 safety trial with only 12 participants, so it is too soon to know if it works. There are risks of infection, bleeding, or worsening of the wound.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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: * Diagnosed with Type 2 Diabetes mellitus (DM) - for at least 1 year * Unilateral non-healing Diabetic Foot Ulcer (DFU) \> 2 cm2 and ≤ 4 cm2 (length × width) for at least four weeks despite Atrium Health Wake Forest Baptist standard of care treatment (which can include total contact cast, knee high air cast, and/or compression wrap) * No new diabetes medication for at least 2 weeks pre-treatment * Subjects must be willing to avoid steroids for the week prior to procedure day Exclusion Criteria: * Clinical signs of active infection requiring systemic antibiotic therapy less than 7 days prior to enrollment. * Radiographic or clinical evidence of active and untreated osteomyelitis at the target ulcer site. Current use of systemic immunosuppressive therapy, including chronic corticosteroids (equivalent to \>10 mg/day prednisone for \>14 days). * Hemoglobin (Hgb) A1C \>12.0 at screening or time in range for the blood glucose level (TIR) less than 30%. Hb A1c should not be used for patient with hypoalbuminemia or anemia in the past 3 months and for patients with Chronic Kidney disease stage 4. For patients who have Continuous Glucose Monitor (CGM), instead of Hb A1c, TIR (time in range) less than 30 % will be used. * Patients who are unable / unwilling to tolerate an effective offloading approach. This includes total contact cast, soft felted cast or knee high fracture boot. * Current alcohol or substance abuse that, in the opinion of the investigators, would interfere with study participation. * Active malignancy or malignancy related limb amputation. * Women that are pregnant or planning to become pregnant during the study. * Patients with albumin levels less than 3.5 or prealbumin levels less than 18. * Subjects with any conditions that the clinical Investigator believes may jeopardize the safety of the patient to participate in the trial. * Severe peripheral arterial disease (PAD) (Ankle-Brachial Index (ABI) less than 0.5) or TCOM (Transcutaneous Oximetry Measurement) less than 40 mmHg. * TWSB \> 30 cm2 (total wound surface burden)
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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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Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
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Other studies related to the condition(s) this trial covers.
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- New wound dressing put to the test against diabetic foot ulcers
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