Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI) (NCT07175129) | Clinical Trial Compass
WithdrawnNot Applicable
Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI)
Stopped: Closed due to slow enrollment.
United States0Started 2026-01-05
Plain-language summary
Chronic limb-threatening ischemia (CLTI) is a serious condition that happens when blood flow to the legs or feet is severely reduced. This can lead to constant pain, wounds that don't heal, infections, and in some cases, the need for amputation.
Some people with CLTI have such severe artery disease that doctors are unable to restore blood flow using standard treatments like surgery or stents. For these patients, major amputation may be the only remaining option.
This study aims to test a new surgical technique called transverse tibial bone transport, which has been shown in some previous small studies to help improve blood flow and promote healing of wounds in the legs and feet. These early studies suggest that the procedure may help wounds heal better and reduce the need for amputation in people with severe circulation problems. This research will help us learn more about how safe and effective this technique is for patients who have no other treatment options other than amputation.
Who can participate
Age range
18 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients avoiding major amputation
Timeframe: Up to 6 months post surgery
2
Percentage of patients achieving complete wound healing as measured by the direct wound observation
Timeframe: Up to 6 months post surgery
3
Percentage of patients achieving a decrease in the Rutherford classification measured by direct observation
Timeframe: Up to 6 months post surgery
4
Changes in lower extremity arterial perfusion measured by ankle-brachial index and toe-brachial index
Timeframe: 1 month, 3 months, and 6 months post surgery
Trial details
NCT IDNCT07175129
SponsorUniversity Hospitals Cleveland Medical Center