NCT07444593 Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds
| NCT ID | NCT07444593 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biodynamik, Inc |
| Condition | Diabetic Foot Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-09-15 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-09-15 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Elizabeth Wellings
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT07444593 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Diabetic Foot Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07444593 currently recruiting?
Yes, NCT07444593 is actively recruiting participants. Contact the research team at Wellings.elizabeth@mayo.edu for enrollment information.
Where is the NCT07444593 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT07444593 clinical trial?
NCT07444593 is sponsored by Biodynamik, Inc. The principal investigator is Elizabeth Wellings at Mayo Clinic. The trial plans to enroll 100 participants.