Transverse Tibial Transport for Chronic Limb-Threatening Ischemia (CLTI)

University Hospitals (UH)

Status

Enrolling

Conditions

Chronic Limb Threatening Ischemia

Treatments

Device: TrueLok Elevate

Procedure: Transverse Tibial Bone Transport

Study type

Interventional

Funder types

Other

Identifiers

NCT07175129

STUDY20250771

Details and patient eligibility

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 95 years old

Volunteers

No Healthy Volunteers

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.