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Chronic Limb Threatening IschemiaNCT07175129

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

A study testing Transverse Tibial Bone Transport and TrueLok Elevate in people with Chronic Limb Threatening Ischemia, run by University Hospitals Cleveland Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 95 years
Conditions the study is for
Chronic Limb Threatening Ischemia
What is being tested?
Transverse Tibial Bone Transport and TrueLok Elevate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
5 Jan 2026to Jun 2027
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Transverse Tibial Bone Transport in "No Option" Patients With Chronic Limb-Threatening Ischemia: A Pilot Study

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.

Being tested
Transverse Tibial Bone Transport, TrueLok Elevate
Keywords
peripheral artery disease, Diabetic Foot
Medical subject headings
Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transverse Tibial Bone TransportProcedure or surgery

    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.

  • TrueLok ElevateDevice

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

Study groups in NCT07175129
Study groupRoleWhat they receive
Transverse Tibial Bone Transport PatientsExperimentalPatients in this arm will undergo transverse tibial bone transport
Receives: Procedure: Transverse Tibial Bone Transport; Device: TrueLok Elevate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients avoiding major amputation

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

    Measured: Up to 6 months post surgery

  2. Percentage of patients achieving complete wound healing as measured by the direct wound observation

    Measured: Up to 6 months post surgery

  3. 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.

    Measured: Up to 6 months post surgery

  4. 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.

    Measured: 1 month, 3 months, and 6 months post surgery

Secondary outcomes (4)

  1. Changes in pain measured by the Visual Analog Scale

    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.

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

  2. Changes in lower extremity neuropathy measured by Semmes-Weinstein Monofilament Test

    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.

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

  3. Changes in quality of life measured by the Short Form-36 (SF-36) scores

    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.

    Measured: 1 month, 2 months, 3 months, and 6 months post surgery

  4. Percentage of patients experiencing adverse outcomes

    All adverse outcomes and complications directly attributable to the transverse tibial bone transport procedure.

    Measured: Up to 6 months post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start5 Jan 2026
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Why it stopped: Closed due to slow enrollment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07175129
Sponsor's protocol ID
STUDY20250771
Status last verified
May 2026
First submitted
14 Sep 2025
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 39369454

  • 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.

    PubMed 37427081

  • 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.

    PubMed 38954658

  • 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.

    PubMed 30116386

  • 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.

    PubMed 35946439

  • 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.

    PubMed 36686461

  • 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.

    PubMed 38318295

Questions about this trial

What is this clinical trial studying?

A study testing Transverse Tibial Bone Transport and TrueLok Elevate in people with Chronic Limb Threatening Ischemia, run by University Hospitals Cleveland Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients avoiding major amputation (time frame: Up to 6 months post surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07175129, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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