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

NCT ID
NCT07444593
Registry status
Recruiting
Study type
Not specified in the registry data
Phase
Not applicable
Sponsor
Biodynamik, Inc

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 100 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following 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

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

  • Florida, United States: 1

Sample of listed locations

  • Mayo Clinic — Jacksonville, Florida, 32224, United States — Site recruitment status not specified in the registry data

Study details

Start date
September 15, 2026
Primary completion date
July 31, 2027
First posted
March 3, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07444593
Registry last updated
September 14, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT07444593 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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