RecruitingDiabetic Foot UlcerChronic Ulcers of the Lower Limb
Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds
Eligible age
22+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Biodynamik, Inc
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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
Where it's recruiting
Florida
Jacksonville
Source: ClinicalTrials.gov · NCT07444593 · last updated 2026-09-14