Transverse tibial bone transport to help heal chronic diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the safety and clinical performance of transverse tibial bone transport (TTT) using the Biodynamik XT3 device for chronic ischemic and diabetic lower-extremity ulcers. Eligible adults 22 years and older with wounds persisting at least 12 weeks and located in the distal tibia or foot, who have some preserved blood flow after revascularization if needed, will undergo the TTT procedure. Outcomes of wound healing and limb preservation will be assessed, alongside safety signals in a population with few effective alternatives. The study acknowledges that traditional options like wound care, revascularization, or adjunct therapies may be insufficient, leaving major amputation as a risk.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Elizabeth Wellings — Mayo Clinic
• Study coordinator: Elizabeth Wellings, MD
• Email: Wellings.elizabeth@mayo.edu
• Phone: 9049532496

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.