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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-05

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Limb Threatening Ischemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Transverse Tibial Bone Transport Patients

Patients in this arm will undergo transverse tibial bone transport

Group Type EXPERIMENTAL

Transverse Tibial Bone Transport

Intervention Type 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.

TrueLok Elevate

Intervention Type DEVICE

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

Interventions

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Transverse Tibial Bone Transport

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.

Intervention Type PROCEDURE

TrueLok Elevate

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No