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NCT07444593

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

Not Yet Recruiting
NAAges 22+InterventionalTreatment
Biodynamik, Inc
~100 participants
Updated 2026-04-27 on ClinicalTrials.gov
What's tested:Biodynamik XT3

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of subjects with wound closure
Measured over From enrollment to 18 weeks

Conditions

Diabetic Foot Ulcer
Chronic Ulcers of the Lower Limb

Explore related trials

Chronic ulcer of lower extremityDiabetic foot ulcer

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Elizabeth Wellings · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Elizabeth Wellings, MD
[email protected]
9049532496
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Proportion of subjects with wound closureFrom 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.