An interventional study of Biodynamik XT3 in Diabetic Foot Ulcer and Chronic Ulcers of the Lower Limb, sponsored by Biodynamik, Inc. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Biodynamik, Inc · Not applicable, Interventional, and Treatment
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.
Diabetic lower extremity ulcers are associated with impaired blood flow, delayed wound healing, high morbidity, and an increased risk of limb loss. In some patients, conventional treatments such as wound care, revascularization procedures, or adjunctive therapies are ineffective or not feasible, leaving limited options short of major amputation.
Transverse tibial bone transport (TTT) is a surgical technique that applies controlled distraction to the tibial cortex and has been reported in prior clinical studies to stimulate angiogenesis, improve local perfusion, and support wound healing in ischemic conditions.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →This is the only study on the registry with Biodynamik, Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Renal function values
Standard Wound Care
Device: Biodynamik XT3
Application of XT3 system and transverse tibial bone transport procedure
Proportion of subjects with wound closure
To demonstrate the safety and effectiveness of the investigational procedure, when used in addition to standard wound care, in promoting clinically meaningful healing of chronic diabetic foot ulcers, specifically, to demonstrate that the proportion of subjects with wound closure is greater for the investigational procedure than standard wound care alone at 18 weeks while maintaining an acceptable safety profile. Proportion of subjects with wound closure as defined as 100% re-epithelialization of the target diabetic foot ulcer where there is no drainage or dressing is not required and confirmed at two consecutive study visits 2 weeks apart.
Time frame: From enrollment to 18 weeks
Proportion of patients with PAR of greater than 60% at 8 and 18 weeks.
The proportion of patients between each cohort who achieve a Percent Area Reduction of greater than 60%
Time frame: At 8 and 18 weeks
Mean PAR summarized at 8 and 18 weeks
To compare mean Percent Area Reduction (PAR) between treatment groups at 8 and 18 weeks
Time frame: From enrollment to 18 weeks
Frequency of subsequent procedures
Frequency of subsequent procedures (surgical debridement; minor/major amputation)
Time frame: From enrollment to 18 weeks
Time to achieve wound closure
Compare the time to achieve wound closure at 18 weeks and through 12 months
Time frame: Enrollment through 18 weeks and 12 months
Vascular changes as measured by Ankle Brachial Index (ABI)
ABI (No units; ratio) at 18 weeks and at 6, 9 and 12 months
Time frame: From enrollment to 18 weeks, 6, 9 and 12 months
Improvement in Visual Analog Scale to measure pain
Improvement in pain as measured in a 10 point Visual Analogue Scale (VAS) at 8 and 18 weeks. VAS lowest score is 0 (no pain). While 10 is the highest score (worst pain).
Time frame: From enrollment to 18 weeks
Frequency of wound recurrence
Frequency of wound recurrence/re-ulceration at 12 weeks and at 6, 9 and 12 months
Time frame: Enrollment until 12 months
Amputation free survival
Amputation free survival at 12 weeks and at 6, 9 and 12 months
Time frame: Enrollment until 12 months
Vascular changes as measured by Transcutaneous Oxygen Pressure (TcPO2)
TcPO2 (mmHG) at 6 weeks, 18 weeks and at 6, 9 and 12 months. Oxygen tension at the skin surface, reflecting tissue oxygenation and perfusion.
Time frame: Measured at baseline to 18 weeks and through 12 months
Improvement in Patient Reported Outcome Wound-QoL-17 at 18 weeks
Improvement in Quality of Life Measure Wound-QoL-17 at 18 weeks. Score (0-4 mean or 0-68 total; Transformed score 0-100
Time frame: From enrollment to 18 weeks
Time to heal for surgical site
Time to heal for pin sites, incision sites and bone consolidation
Time frame: Enrollment to 18 weeks
Safety Endpoint - Adverse Events
• Frequency of treatment-emergent serious and non-serious adverse events
Time frame: Enrollment to 18 weeks
Safety endpoint - TTT Related
Frequency of device-related adverse events in the TTT arm including pin site infection and device breakage
Time frame: Enrollment to 18 weeks
Plasma growth factor level changes as measured by VEGf at 18 weeks and at 6,9 and 12 months
Vascular Endothelial Growth Factor) measured in either picograms per milliliter (pg/mL) or nanograms per liter (ng/L) in serum or plasma
Time frame: From enrollment until 12 months
Vascular Perfusion measured by Computed Tomography Angiogram (CTA) at 18 weeks and at 6, 9 and 12 months
CTA is measured in Hounsfield Units (HU)
Time frame: Through 12 months
Plan to share: No
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