Status:
NOT_YET_RECRUITING
Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI)
Lead Sponsor:
University Hospitals Cleveland Medical Center
Conditions:
Chronic Limb Threatening Ischemia
Eligibility:
All Genders
18-95 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07175129
Start Date
January 1 2026
End Date
June 1 2027
Last Update
November 20 2025
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106