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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

100

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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

Biodynamik, Inc

Collaborators

Mayo Clinic

Investigators

  • 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)

May 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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