Stem cell shot may heal diabetic foot sores
NCT ID NCT05595681
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tested whether stem cells from donated fat tissue could help heal foot ulcers in people with diabetes. 21 adults aged 40-75 with a foot ulcer below the ankle were enrolled. The study compared stem cell treatment to standard care, but the trial was terminated early, so results are limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stem cells from donated fat tissue
- What this could lead to
- If successful, this could point toward a new treatment to help heal diabetic foot ulcers faster.
- What could go wrong
- This is a very early phase 1 pilot study with only 21 participants, and it was terminated early. The results may not be reliable or apply to all patients.
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
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
21 people
The number who actually took part.
- Started
-
Dec 2022
- Finished
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Nov 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
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: * Diagnosis of diabetes mellitus for at least 3 months. * Age 40-75 years. * A foot ulcer below the level of the malleoli, excluding ulcers confined to the digits or interdigital cleft. If more than one ulcer, the largest will be selected at screening as the index ulcer. * Wound area after sharp debridement of ≥ 50 mm\^2, but ≤1000 mm\^2. Exclusion Criteria: * Signs of infection of the index ulcer. * An ulcer where a probe investigation indicates ulcer depth to the underlying bone. * Wound caused primarily by untreated vascular insufficiency, or where participants are primarily eligible for vascular intervention to promote wound healing. * Wounds with an etiology not related to diabetes. * Underlying osteomyelitis of the leg with the wound to be treated. * Participants presenting with the clinical characteristics of cellulitis at the wound site (suppurative inflammation involving particularly the subcutaneous tissue, often mild erythema, tenderness, malaise, chills and fever). * Surgery to lengthen achilles tendon on the leg with the wound to be treated 3 months prioer to signing the informed consent form. * Necrosis, purulence, or sinus tracts that cannon be removed by debridement on foot to be treated. * Toe blood pressure \< 44 mmHg at the foot with the index ulcer. * Dialysis or an estimated glomerular filtration rate (GFR) (based on serum creatinine) \< 20 ml/min/1.73 m\^2. * Current treatment with cytotoxic drugs. * Hospitalisation for a major cardiovascular event or procedure or revascularization surgery on a leg in the last 3 months or scheduled major cardiovascular intervention. * Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocol. * Recent use (\< 3 months) of an investigational drug or participation in interventional clinical foot ulcer-healing trial. * Females capable of becoming pregnant must have a negative pregnancy test prior to transplantation. After inclusion, they must use contraceptives for 12 weeks following the given stem cell treatment. The pill, spirak, depot injection of progesterone, sub-dermal implantation, hormonal vaginal ring and transdermal patch regarded as safe contraceptives. * Likely inability yo comply with the need for clinical visits because of planned activity. * Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation. * Unable to provide written and signed informed consent. * Any clinically significant disease or disorder, except for conditions associated to the type 1 or 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial. * Active cancer or a history of cancer in the 5 years prior to signing the informed consent form (history of basal cell carcinoma is allowed). * Life expectancy of less than 12 months.
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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.
Contacts and locations
Locations
-
Copenhagen Diabetes Foot Center (CODIF)
Copenhagen, Denmark
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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