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

Not Applicable

Not yet recruiting

• Conditions: Chronic Limb Threatening Ischemia

• Registration Number: NCT07175129
• Lead Sponsor: University Hospitals Cleveland Medical Center

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, 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-14
• Study First Submitted QC: 2025-09-14
• Last Update Submitted: 2025-09-14
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2025-10-01
• Primary Completion: 2027-06
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of patients avoiding major amputation	Up to 6 months post surgery	major amputation refers to the surgical removal of a limb anywhere above the ankle joint
Percentage of patients achieving complete wound healing as measured by the direct wound observation	Up to 6 months post surgery
Percentage of patients achieving a decrease in the Rutherford classification measured by direct observation	Up to 6 months post surgery	The Rutherford wound classification is an observational technique to assess the severity of peripheral artery disease of the lower limb on a scale of 0 being asymptomatic to 6 being major tissue loss.
Changes in lower extremity arterial perfusion measured by ankle-brachial index and toe-brachial index	1 month, 3 months, and 6 months post surgery	The Ankle-Brachial Index (ABI) and Toe-Brachial Index (TBI) are noninvasive measures of lower-extremity arterial perfusion, calculated as the ratio of the highest systolic blood pressure at the ankle or great toe, respectively, to the highest systolic blood pressure at the brachial artery. Lower ABI and TBI values on indicate greater arterial obstruction.

Secondary Outcome Measures

Name	Time	Method
Changes in pain measured by the Visual Analog Scale	1 week, 2 weeks, 1 month, 2 months, 3 months, and 6 months post surgery	The Visual Analogue Scale (VAS) is a simple tool used to measure the intensity of pain. It typically consists of a 100 mm horizontal line anchored by two extremes, such as "No pain" on the left and "Worst imaginable pain" on the right.; Participants mark a point along the line that best represents their experience, and the distance from the "no pain" end to the mark is measured in millimeters to produce a score from 0 to 100.
Changes in lower extremity neuropathy measured by Semmes-Weinstein Monofilament Test	1 week, 2 weeks, 1 month, 2 months, 3 months, and 6 months post surgery	The Semmes-Weinstein Monofilament Test is a standardized assessment of light touch and protective sensation using calibrated nylon filaments, with inability to perceive the 10-gram (5.07) monofilament at specified sites indicating loss of protective sensation.
Changes in quality of life measured by the Short Form-36 (SF-36) scores	1 month, 2 months, 3 months, and 6 months post surgery	The Short Form-36 (SF-36) Health Survey is a validated 36-item questionnaire assessing eight domains of health-related quality of life, with scores for each domain ranging from 0 to 100, where higher scores indicate better perceived health status.
Percentage of patients experiencing adverse outcomes	Up to 6 months post surgery	All adverse outcomes and complications directly attributable to the transverse tibial bone transport procedure.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States