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

Sponsored by University Hospitals Cleveland Medical Center

About this trial

Last updated 4 months ago

Study ID

STUDY20250771

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 95 Years

All Sexes

Trial Timing

Started 4 months ago

What is this trial 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.

What are the participation requirements?

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.