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New Bone-Moving surgery could help avoid amputation in 'No Option' patients

NCT ID NCT07175129

Disease control Sponsor: University Hospitals Cleveland Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study was designed to test a new surgical technique called transverse tibial bone transport in people with chronic limb-threatening ischemia (CLTI) who have no standard treatment options left. The procedure involves slowly moving a small piece of shinbone to stimulate new blood vessel growth and help heal wounds. The goal was to see if it could prevent major amputation and improve blood flow, but the study was withdrawn before any patients were enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transverse Tibial Bone Transport procedure
What this could lead to
If it works, this could offer a way to save the leg and avoid amputation for people with severe circulation problems who have run out of standard treatments.
What could go wrong
This is a very early pilot study that was withdrawn before enrolling anyone, so we have no results yet. The procedure is new and unproven, and there may be risks like infection or bone healing problems.

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.

Started

Jan 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 95 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age above 18 years and under 95 years * History of diabetes mellitus with stable glycemic control (HbA1C\<10) * Clinical diagnosis of chronic limb-threatening ischemia * Stable Rutherford Classification 5 or 6 ischemic ulcer on foot * Subjects who are determined by an independent multidisciplinary team of surgical and endovascular experts to have no feasible conventional distal bypass surgical or endovascular therapy for limb salvage. * Subjects who are enrolled in an appropriate wound care network and have a sufficient support system to ensure compliance with medication regimens and follow-up study visits. * Subjects who are willing and able to provide informed consent Exclusion Criteria: * Frailty or severe comorbidities including significantly reduced cardiac, hepatic, renal and respiratory insufficiency making the subject not fit for surgery * Active malignancy or immunodeficiency disorder * Previous major amputation of the target limb or presence of a wound requiring a free flap * Life expectancy less than 12 months * Active infection at the time of the index procedure * Any significant concurrent medical, psychological, or social condition that, in the opinion of the investigator, may substantially interfere with the subject's optimal participation in the study. * Pregnancy at the time of enrolment * The subject participating in another investigational drug or device study that has not completed its primary endpoint or clinically interferes with the endpoints of this study. * The subject is unwilling or unable to comply with any protocol or follow-up requirements.

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Conditions

The condition(s) this trial relates to.

Chronic Limb-Threatening Ischemia Diabetic Foot limb ischemia peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic limb-threatening ischemia

Contacts and locations

Locations

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.