Transverse Tibial Bone Transport for Critical Limb Ischemia

Overseen By Mehdi Shishehbor, DO, MPH, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Frailty, Active malignancy, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Immediate

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new surgery called transverse tibial bone transport to assist individuals with chronic limb-threatening ischemia (CLTI), a condition where blood flow to the legs or feet is severely reduced. CLTI can cause severe pain, non-healing wounds, and may sometimes lead to amputation. The surgery aims to enhance blood flow and heal wounds, potentially reducing the need for amputation. This trial targets individuals with CLTI, diabetes, and a non-healing foot ulcer who have exhausted other treatment options. As an unphased trial, it provides a unique opportunity for patients to access a potentially life-changing treatment when no other options remain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mentions that participants must be able to comply with medication regimens, suggesting you may continue your current medications, but it's best to confirm with the study team.

What prior data suggests that this surgical technique is safe for patients with critical limb ischemia?

Research has shown that transverse tibial bone transport is generally well-tolerated by individuals with severe circulation problems in their legs or feet. In previous studies, this surgical method improved blood flow and wound healing while reducing the need for amputation.

One study found that the procedure had a high success rate in healing and saving limbs, improving blood flow, skin temperature, and pain levels. Another study found that using this technique alongside other treatments was safe.

Although some side effects were reported up to six months after surgery, past research indicates that the procedure is generally safe. This suggests it could be a viable option for those with no other treatment choices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for critical limb ischemia, which often include medications to improve blood flow or surgeries like bypass and angioplasty, transverse tibial bone transport is a novel technique that focuses on promoting new tissue growth. This method involves gradually moving a segment of the tibial bone to stimulate the development of new blood vessels and tissue, potentially enhancing circulation in the affected limb. Researchers are excited about this approach because it offers a new way to address the root cause of the condition by fostering natural regeneration, which could lead to improved outcomes for patients who have limited options with current treatments.

What evidence suggests that transverse tibial bone transport is effective for chronic limb-threatening ischemia?

Research has shown that transverse tibial bone transport, a procedure participants in this trial will undergo, can help treat severe blood flow problems in the legs, known as chronic limb-threatening ischemia (CLTI). Studies have found that this procedure often aids in wound healing and limb preservation, preventing amputation. Patients have experienced better blood flow and improved wound healing, with some reports of ulcers healing in about five months. The procedure also improved blood flow measurements, skin temperature, and pain levels. Overall, these findings suggest that this technique might be a promising option for patients with serious circulation issues in their legs. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with severe Chronic Limb-Threatening Ischemia (CLTI) who haven't had success with standard treatments like surgery or stents and are facing potential amputation. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria to undergo the surgical procedure.

Inclusion Criteria

Subjects 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 willing and able to provide informed consent

Experts say I can't have standard surgery or procedures to save my limb.

Exclusion Criteria

Life expectancy less than 12 months

I have severe health issues that make surgery too risky for me.

I have an active cancer or a condition that weakens my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo transverse tibial bone transport surgery

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular visits at 1 week, 2 weeks, 1 month, 2 months, 3 months, and 6 months post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Transverse Tibial Bone Transport

Trial Overview The study tests a new surgical technique called transverse tibial bone transport using TrueLok Elevate system. It's designed for those whose CLTI has not improved with usual care, aiming to enhance blood flow and wound healing in legs and feet, potentially reducing amputation needs.

How Is the Trial Designed?

Group I: Transverse Tibial Bone Transport Patients Experimental Treatment 2 Interventions

Patients in this arm will undergo transverse tibial bone transport

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9846025/

Effectiveness of transverse tibial bone transport in treatment of ... TTT operation was associated with high healing rate and limb salvage rate, and could significantly improve the ABI, skin temperature, and VAS after operation.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07175129

Transverse Tibial Transport for Chronic Limb-Threatening ... Effectiveness of transverse tibial bone transport in treatment of diabetic foot ulcer: A systematic review and meta-analysis. Front ...

3. fastracjournal.org fastracjournal.org/article/S2667-3967(25)00048-5/fulltext

Tibial cortex transverse transport: Historical evolution, clinical ... All patients achieved 100 % limb salvage, with ulcers healing in an average of 5.3 months and improvement in inflammatory markers. Since then, multiple primary ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2210261225006947

Transverse tibial bone transport to avoid major lower limb ... The study by Chen et al. further examined the efficacy of transverse tibial bone transport in patients with critical limb ischemia complicated by diabetic foot ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/os.14222

Combining Tibial Cortex Transverse Transport (TTT) and ... TABLE 2. Outcomes of combining Tibial cortex transverse distraction and endovascular therapy for chronic limb-threatening ischemia (CLTI).

6. sciencedirect.com sciencedirect.com/science/article/pii/S2667396725000485

Tibial cortex transverse transport: Historical evolution ... compared the outcomes of TCT against percutaneous transluminal balloon angioplasty (PTBA) in 90 patients with chronic lower limb ischemia. The TCT group ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/10711007251341312

A Systematic Review on Tibial Cortex Transverse ... A total of 13 articles were included in the final selection, involving 924 patients, with 724 treated with TTT, in which 701 were diabetic ...