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New surgical trick could save diabetic feet from amputation

NCT ID NCT07444593

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

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

22 years and older

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

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