Transverse tibial bone transport to improve blood flow and healing in severe leg and foot ischemia
Transverse Tibial Bone Transport in "No Option" Patients With Chronic Limb-Threatening Ischemia: A Pilot Study
This study will try a surgical bone-transport technique to improve blood flow and help wounds heal in adults with severe chronic limb-threatening ischemia who have no other revascularization options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07175129 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls adults with chronic limb-threatening ischemia (Rutherford class 5 or 6) who are not candidates for conventional bypass or endovascular revascularization. Participants will undergo transverse tibial bone transport using an external fixation system (TrueLok Elevate) to stimulate local blood flow and wound healing. Investigators will follow patients for safety, wound healing, limb salvage, and procedural outcomes. The approach builds on small prior reports suggesting improved perfusion and reduced amputation rates but requires larger, systematic evaluation.
Who should consider this trial
Good fit: Adults aged 18–95 with diabetes and stable glycemic control (HbA1c under 10%), clinical CLTI with Rutherford 5 or 6 ulcers, who have been judged by a multidisciplinary team to have no feasible conventional distal bypass or endovascular option and who can comply with wound-care and follow-up.
Not a fit: Patients who are frail or have severe cardiac, hepatic, renal, or respiratory insufficiency, active malignancy or immunodeficiency, or prior major amputation of the target limb are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the procedure could improve blood flow, speed healing of ischemic foot wounds, and reduce the need for major amputation in patients with no other treatment options.
How similar studies have performed: Earlier small case series and pilot reports have suggested this transverse tibial bone transport technique can increase local perfusion and promote wound healing, but larger controlled data are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Mehdi Shishehbor, DO, MPH, PhD
- Email: mehdi.shishehbor@uhhospitals.org
- Phone: (216) 844-5170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.