Recruiting

Transverse Tibial Bone Transport

Sponsor:

Biodynamik, Inc

Code:

NCT07444593

Conditions

Diabetic Foot Ulcer

Chronic Ulcers of the Lower Limb

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Biodynamik XT3

Study Details

Brief summary:

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.

Conditions

Diabetic Foot Ulcer

Chronic Ulcers of the Lower Limb

Study ID

NCT07444593

Start date

Sep 15, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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
  • Lab values of Serum albumin less than 2.5 g/dL or hemoglobin less than 8.0 g/dL or platelet count less than 75,000/μL
  • Wounds less than 1 cm3 or greater than 30 cm3
  • Wounds that are circumferential as defined as a wound involving 360° of the limb circumference, with complete circumferential wounds defined as 360° involvement.
  • Corticosteroids >10mg prednisone equivalent daily for >2 weeks
  • Patients with osteomyelitis in the ipsilateral tibia at planned corticotomy site
  • TNF-inhibitors or JAK inhibitors or chemotherapy-dose methotrexate
  • 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 >10
  • BMI <18.5 kg/m2
  • Pregnant, lactating, or planning to become pregnant
  • Severe hepatic impairment defined by patient on a transplant list, MELD > 20 or 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.
  • Active local wound infection as defined by erythema greater than 0.5 cm from the wound margin AND at least one other localized sign of inflammation (purulent discharge, induration, localized warmth, or pain/tenderness)
  • Life expectancy less than 12 months

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard of Care (control)

Standard Wound Care

experimental: Standard Wound Care plus TTT

Interventions

Biodynamik XT3

Application of XT3 system and transverse tibial bone transport procedure

Primary outcome measure

  • Proportion of subjects with wound closure [ Time Frame: From enrollment to 18 weeks ]

Central Contacts and Locations

Central contacts

Elizabeth Wellings, MD

9049532496Wellings.elizabeth@mayo.edu

Lauren Evans

evans.lauren2@mayo.edu

Locations

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Lauren Evans

904-953-5416evans.lauren2@mayo.edu

Bre Jenkins

jenkins.breana@mayo.edu

Principal Investigator:

Elizabeth Wellings, MD

More Information

Sponsor

Biodynamik, Inc

Last update posted

Sep 10, 2026

Last verified

Sep, 2026

Keywords

  • Transverse Bone Transport
  • DFU
  • TTT
  • Biodynamik
  • XT3

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Biodynamik, Inc on 2026-09-10.