New surgical trick could save diabetic feet from amputation
NCT ID NCT07444593
First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 5 times
Summary
This study tests a device that moves a small piece of shinbone to improve blood flow and help heal chronic foot ulcers in people with diabetes. One hundred adults with stubborn ulcers that haven't healed after 12 weeks will be enrolled. The goal is to see if this procedure, added to standard wound care, leads to more complete wound healing compared to standard care alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Biodynamik XT3 device and transverse tibial bone transport procedure
- What this could lead to
- If successful, this could offer a new surgical option to heal stubborn diabetic foot ulcers and reduce the need for leg amputation.
- What could go wrong
- This is an early study with only 100 people, so results may not apply to everyone. The procedure is surgical and carries risks like infection or poor healing.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 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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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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22 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: * Adults (\>=22 years). * Chronic diabetic foot ulcer wound persisting \>=12 weeks and less than 104 weeks refractory to standard wound care. * Wound location within distal 1/3 tibia and below including foot. * Wound stages: WiFi \>= 3 * At least one patent lower extremity tibial vessel (after revascularization if needed). * Able to provide informed consent and comply with study procedures. Exclusion Criteria: * Active systemic infection (positive blood cultures) * Severe sepsis (2 out of 4 SIRS criteria with impact on organ dysfunction) * Subacute lower extremity wound \<12 weeks with or without standard wound cares * Internal hardware within 10cm of possible TTT placement * Most proximal aspect of wound within 10cm of most distal pin of possible TTT placement * End Stage Renal Disease requiring dialysis * Renal function values * eGFR: \<15ml/min and * Creatinine: \>6mg/dL and * BUN: \>50 mg/dL * Lab values of Serum albumin less than 2.5 g/dL or hemoglobin less than 8.0 g/dL or platelet count less than 75,000/μL * Wounds less than 1 cm3 or greater than 30 cm3 * Wounds that are circumferential as defined as a wound involving 360° of the limb circumference, with complete circumferential wounds defined as 360° involvement. * Corticosteroids \>10mg prednisone equivalent daily for \>2 weeks * Patients with osteomyelitis in the ipsilateral tibia at planned corticotomy site * TNF-inhibitors or JAK inhibitors or chemotherapy-dose methotrexate * Cognitive or social limitations precluding consent or follow-up * Current participation in another investigational study (drug or device) * Immunocompromised (WBC \<4) or undergoing active chemotherapy * Hemoglobin A1c \>10 * BMI \<18.5 kg/m2 * Pregnant, lactating, or planning to become pregnant * Severe hepatic impairment defined by patient on a transplant list, MELD \> 20 or Child's class C. * A history of conditions that may impair wound healing in the opinion of the Investigator, for example, autoimmune disorders, renal failure patients on dialysis, or medications that impair the healing process. * Active local wound infection as defined by erythema greater than 0.5 cm from the wound margin AND at least one other localized sign of inflammation (purulent discharge, induration, localized warmth, or pain/tenderness) * Life expectancy 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.
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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Mayo Clinic
RECRUITINGJacksonville, Florida, 32224, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gene therapy shots aim to save legs from amputation in diabetes
- New wound dressing put to the test against diabetic foot ulcers
- Silver and sound: can ultrasound push nanoparticles into diabetic wounds?
- Zapping a leg nerve: can a wearable device help stubborn ulcers heal?
- Wound dressings that trap microbes: scientists test a Drug-Free approach
- Can a traditional herbal mix save limbs from diabetic ulcers?