Actively Recruiting
Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI)
Led by University Hospitals Cleveland Medical Center · Updated on 2026-01-28
10
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Determined by an independent multidisciplinary team to have no feasible conventional distal bypass surgical or endovascular therapy for limb salvage
- Enrolled in an appropriate wound care network with sufficient support system for medication compliance and follow-up
- Willing and able to provide informed consent
You will not qualify if you...
- Frailty or severe comorbidities including significantly reduced cardiac, hepatic, renal and respiratory function making surgery unsafe
- 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 time of surgery
- Any significant medical, psychological, or social condition that may interfere with study participation
- Pregnancy at time of enrollment
- Participation in another investigational drug or device study that is ongoing or interferes with this study
- Unwilling or unable to comply with protocol or follow-up requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
M
Mehdi Shishehbor, DO, MPH, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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