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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