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

NCT07175129 | Recruiting FDA Device

• 1 other identifier: STUDY20250771
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Limb Threatening Ischemia

Keywords

peripheral artery disease; Diabetic Foot

Outcome Measures

Primary Outcomes (4)

• Percentage of patients avoiding major amputation

  major amputation refers to the surgical removal of a limb anywhere above the ankle joint

  Up to 6 months post surgery

• 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

  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.

  Up to 6 months post surgery

• Changes in lower extremity arterial perfusion measured by ankle-brachial index and toe-brachial index

  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.

  1 month, 3 months, and 6 months post surgery

Secondary Outcomes (4)

• Changes in pain measured by the Visual Analog Scale

  1 week, 2 weeks, 1 month, 2 months, 3 months, and 6 months post surgery

• 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

• 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

• Percentage of patients experiencing adverse outcomes

  Up to 6 months post surgery

Study Arms (1)

Transverse Tibial Bone Transport Patients

EXPERIMENTAL

Patients in this arm will undergo transverse tibial bone transport

Procedure: Transverse Tibial Bone Transport; Device: TrueLok Elevate

Interventions

Transverse Tibial Bone Transport PROCEDURE

Tibial tibial bone transport is a novel surgical procedure that involves the gradual movement of a bone segment in order to improve perfusion and tissue healing.

Transverse Tibial Bone Transport Patients

TrueLok Elevate DEVICE

This device is used to move the bone segment as a part of the tibial bone transport surgery.

Transverse Tibial Bone Transport Patients

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Related Publications (7)

• Yang AA, Park N, Gazes MI, Samchukov M, Frumberg DB. Transverse tibial bone transport for non-healing heel wound: A case report. Int J Surg Case Rep. 2024 Nov;124:110400. doi: 10.1016/j.ijscr.2024.110400. Epub 2024 Oct 2.

  PMID: 39369454 BACKGROUND

• Wen R, Cheng X, Cao H, Zhang L, Luo F, Shang W. Transverse Tibial Bone Transfer in the Treatment of Diabetes Foot Ulcer: A Pilot Study. Diabetes Metab Syndr Obes. 2023 Jul 3;16:2005-2012. doi: 10.2147/DMSO.S413884. eCollection 2023.

  PMID: 37427081 BACKGROUND

• Yu L, Zhang D, Yin Y, Li X, Bai C, Zhou Q, Liu X, Tian X, Xu D, Yu X, Zhao S, Hu R, Guo F, Yang Y, Ren Y, Chen G, Zeng J, Feng J. Tibial cortex transverse transport surgery improves wound healing in patients with severe type 2 DFUs by activating a systemic immune response: a cross-sectional study. Int J Surg. 2025 Jan 1;111(1):257-272. doi: 10.1097/JS9.0000000000001897.

  PMID: 38954658 BACKGROUND

• Zuo Q, Gao F, Song H, Zhou J. Application of Ilizarov transverse tibial bone transport and microcirculation reconstruction in the treatment of chronic ischemic diseases in lower limbs. Exp Ther Med. 2018 Aug;16(2):1355-1359. doi: 10.3892/etm.2018.6321. Epub 2018 Jun 18.

  PMID: 30116386 BACKGROUND

• Ou S, Xu C, Yang Y, Chen Y, Li W, Lu H, Li G, Sun H, Qi Y. Transverse Tibial Bone Transport Enhances Distraction Osteogenesis and Vascularization in the Treatment of Diabetic Foot. Orthop Surg. 2022 Sep;14(9):2170-2179. doi: 10.1111/os.13416. Epub 2022 Aug 10.

  PMID: 35946439 BACKGROUND

• Hu XX, Xiu ZZ, Li GC, Zhang JY, Shu LJ, Chen Z, Li H, Zou QF, Zhou Q. Effectiveness of transverse tibial bone transport in treatment of diabetic foot ulcer: A systematic review and meta-analysis. Front Endocrinol (Lausanne). 2023 Jan 4;13:1095361. doi: 10.3389/fendo.2022.1095361. eCollection 2022.

  PMID: 36686461 BACKGROUND

• Liu J, Yao X, Xu Z, Wu Y, Pei F, Zhang L, Li M, Shi M, Du X, Zhao H. Modified tibial cortex transverse transport for diabetic foot ulcers with Wagner grade >/= II: a study of 98 patients. Front Endocrinol (Lausanne). 2024 Jan 22;15:1334414. doi: 10.3389/fendo.2024.1334414. eCollection 2024.

  PMID: 38318295 BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease; Diabetic Foot

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Diabetic Angiopathies; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Mehdi Shishehbor, DO, MPH, PhD

CONTACT

(216) 844-5170; mehdi.shishehbor@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, University Hospitals Harrington Heart and Vascular Institute

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 16, 2025
• Study Start: January 5, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)