Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds

April 22, 2026 updated by: Biodynamik, Inc

SMILE - TTT: Surgical MIcrovascularization of Lower Extremities for Diabetic Foot Ulcers - Transverse Tibial Transport Study

The purpose of this study is to evaluate the safety and clinical performance of transverse tibial bone transport in patients with chronic ischemic and diabetic lower extremity ulcers. This study will assess wound healing outcomes and limb preservation in a population with limited therapeutic alternatives.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Diabetic lower extremity ulcers are associated with impaired blood flow, delayed wound healing, high morbidity, and an increased risk of limb loss. In some patients, conventional treatments such as wound care, revascularization procedures, or adjunctive therapies are ineffective or not feasible, leaving limited options short of major amputation.

Transverse tibial bone transport (TTT) is a surgical technique that applies controlled distraction to the tibial cortex and has been reported in prior clinical studies to stimulate angiogenesis, improve local perfusion, and support wound healing in ischemic conditions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults (>=22 years).
  • Chronic diabetic foot ulcer wound persisting >=12 weeks and less than 104 weeks refractory to standard wound care.
  • Wound location within distal 1/3 tibia and below including foot.
  • Wound stages: WiFi >= 3
  • At least one patent lower extremity tibial vessel (after revascularization if needed).
  • Able to provide informed consent and comply with study procedures.

Exclusion Criteria:

  • Active systemic infection (positive blood cultures)
  • Severe sepsis (2 out of 4 SIRS criteria with impact on organ dysfunction)
  • Subacute lower extremity wound <12 weeks with or without standard wound cares
  • Internal hardware within 10cm of possible TTT placement
  • Most proximal aspect of wound within 10cm of most distal pin of possible TTT placement
  • End Stage Renal Disease requiring dialysis

  • Renal function values

    • eGFR: <15ml/min and
    • Creatinine: >6mg/dL and
    • BUN: >50 mg/dL
  • Wounds less than 1 cm3 or greater than 30 cm3
  • Corticosteroids >10mg prednisone equivalent daily for >2 weeks
  • Patients with osteomyelitis in the ipsilateral tibia at planned corticotomy site
  • Cognitive or social limitations precluding consent or follow-up
  • Current participation in another investigational study (drug or device)
  • Immunocompromised (WBC <4) or undergoing active chemotherapy
  • Hemoglobin A1c >12
  • BMI <18.5 kg/m2
  • Pregnant, lactating, or planning to become pregnant
  • Life expectancy less than 12 months
  • Severe hepatic impairment defined by patient on a transplant list, MELD > 20, Child's class C.
  • A history of conditions that may impair wound healing in the opinion of the Investigator, for example, autoimmune disorders, renal failure patients on dialysis, or medications that impair the healing process.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard of Care (control)
Standard Wound Care
Experimental: Standard Wound Care plus TTT
Device: Biodynamik XT3
Application of XT3 system and transverse tibial bone transport procedure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects with wound closure
Time Frame: From enrollment to 18 weeks
To demonstrate the safety and effectiveness of the investigational procedure, when used in addition to standard wound care, in promoting clinically meaningful healing of chronic diabetic foot ulcers, specifically, to demonstrate that the proportion of subjects with wound closure is greater for the investigational procedure than standard wound care alone at 18 weeks while maintaining an acceptable safety profile. Proportion of subjects with wound closure as defined as 100% re-epithelialization of the target diabetic foot ulcer where there is no drainage or dressing is not required and confirmed at two consecutive study visits 2 weeks apart.
From enrollment to 18 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of wound recurrence
Time Frame: Enrollment until 12 months
Frequency of wound recurrence/re-ulceration at 12 weeks and at 6, 9 and 12 months
Enrollment until 12 months
Amputation free survival
Time Frame: Enrollment until 12 months
Amputation free survival at 12 weeks and at 6, 9 and 12 months
Enrollment until 12 months
Mean PAR summarized at 8 and 18 weeks
Time Frame: From enrollment to 18 weeks
To compare mean Percent Area Reduction (PAR) between treatment groups at 8 and 18 weeks
From enrollment to 18 weeks
Proportion of patients with greater than 60% PAR
Time Frame: From enrollment until 18 weeks
To compare the proportion of patients with PAR of greater than 60% at 8 and 18 weeks..
From enrollment until 18 weeks
Frequency of subsequent procedures
Time Frame: From enrollment to 18 weeks
Frequency of subsequent procedures (surgical debridement; minor/major amputation)
From enrollment to 18 weeks
Vascular changes as measured by Ankle Brachial Index (ABI)
Time Frame: From enrollment to 18 weeks, 6, 9 and 12 months
ABI (No units; ratio) at 18 weeks and at 6, 9 and 12 months
From enrollment to 18 weeks, 6, 9 and 12 months
Improvement in Visual Analog Scale to measure pain
Time Frame: From enrollment to 18 weeks
Improvement in pain as measured in a 10 point Visual Analogue Scale (VAS) at 8 and 18 weeks. VAS lowest score is 0 (no pain). While 10 is the highest score (worst pain).
From enrollment to 18 weeks
Vascular changes as measured by Transcutaneous Oxygen Pressure (TcPO2)
Time Frame: Measured at baseline to 18 weeks and through 12 months
TcPO2 (mmHG) at 6 weeks, 18 weeks and at 6, 9 and 12 months. Oxygen tension at the skin surface, reflecting tissue oxygenation and perfusion.
Measured at baseline to 18 weeks and through 12 months
Improvement in Patient Reported Outcome Wound-QoL-17 at 16 weeks
Time Frame: From enrollment to 18 weeks
Improvement in Quality of Life Measure Wound-QoL-17 at 18 weeks. Score (0-4 mean or 0-68 total; Transformed score 0-100
From enrollment to 18 weeks
Time to achieve wound closure
Time Frame: Enrollment through 18 weeks and 12 months
Compare the time to achieve wound closure at 18 weeks and through 12 months
Enrollment through 18 weeks and 12 months
Time to heal for surgical site
Time Frame: Enrollment to 18 weeks
Time to heal for pin sites, incision sites and bone consolidation
Enrollment to 18 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety Endpoint - Adverse Events
Time Frame: Enrollment to 18 weeks
• Frequency of treatment-emergent serious and non-serious adverse events
Enrollment to 18 weeks
Safety endpoint - TTT Related
Time Frame: Enrollment to 18 weeks
Frequency of device-related adverse events in the TTT arm including pin site infection and device breakage
Enrollment to 18 weeks
Plasma growth factor level changes as measured by VEGf at 18 weeks and at 6,9 and 12 months
Time Frame: From enrollment until 12 months
Vascular Endothelial Growth Factor) measured in either picograms per milliliter (pg/mL) or nanograms per liter (ng/L) in serum or plasma
From enrollment until 12 months
Vascular Perfusion measured by Computed Tomography Angiogram (CTA) at 18 weeks and at 6, 9 and 12 months
Time Frame: Through 12 months
CTA is measured in Hounsfield Units (HU)
Through 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biodynamik, Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Wellings, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BD-TTT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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