Can your own fat heal chronic wounds? small study aims to find out
NCT ID NCT02375802
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tests whether a person's own fat stem cells can safely help heal pressure ulcers or diabetic foot ulcers. Twelve adults will have a small amount of fat removed from their body, processed to extract stem cells, and then applied to their wound using a special sealant. Researchers will watch for side effects and wound healing over six weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a patient's own fat-derived stem cells (adipose-derived stromal cells) mixed with a fibrin sealant
- What this could lead to
- If successful, this could point toward a new way to help heal chronic wounds like pressure ulcers and diabetic foot ulcers.
- What could go wrong
- This is a very early, small pilot study with only 12 people. It mainly checks safety, not effectiveness, and the treatment may not work or could cause infection or bleeding.
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.
- Start date
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Jul 2015
- Expected to finish
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Dec 2027
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 * Males and females * Stage III pressure ulcers measuring 5 cc - 36 cc in volume (as measured by filling the wound with Normal Saline). * Inpatient or outpatient treatment of pressure ulcers * Diabetic Foot Ulcer Stage 1 or 2 of any size * Co-morbidities may include: * Peripheral Vascular Disease (PVD) * Coronary Artery Disease (CAD) * Chronic Renal Disease (CRD) * Chronic Liver Disease (CLD) * Hypertension (HTN) * Diabetes * The ability of subjects to give appropriate consent or have an appropriate representative available to do so * The ability of subjects to return for weekly wound assessments Exclusion Criteria * Patients with allergies to TISSEEL, Tegaderm, or silicon * Diabetics with poor glucose metabolic control (HbA1c \> 9) * Target wounds that are in close proximity to potential cancerous lesions * Patients who require Negative Pressure Wound Therapy (NPWT), limb amputation, or surgical intervention at the target wound at the time of screening * Wounds located on the face * Patients with Stage 5 or 6 Peripheral Vascular disease (specifically, wounds that are caused by peripheral vascular disease such as leg ulcers) * Wounds caused by diabetes mellitus (diabetic foot ulcers). * BMI of \<16 Clinical signs of critical colonization or local infection * Prolonged (\> 6 months) use of steroids * Patients on active regimen of chemotherapy * Patients receiving radiation in proximity of wound * Decompensated chronic liver disease
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
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Other studies related to the condition(s) this trial covers.
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- New mineral spray shows promise for faster wound healing
- Hidden danger: blood clot prevention device may cause pressure sores
- Can fatty acids beat dressings to stop bedsores in prone patients?