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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Application of XT3 system and transverse tibial bone transport procedure
Mayo Clinic
Jacksonville, Florida, United States
Time to Wound Closure
To demonstrate the effectiveness of the investigational procedure, when used in addition to standard wound care, in promoting clinically meaningful healing of chronic lower extremity wounds, specifically, to demonstrate that the time to achieving wound closure is faster for the investigational procedure than standard wound care alone.
Time frame: From enrollment to 16 weeks
Mean Percent Area Reduction (PAR) at 16 weeks
To compare mean Percent Area Reduction (PAR) between treatment groups at 16 weeks
Time frame: From enrollment to 16 weeks
Proportion of patients with wound closure
To compare the proportion of patients with wound closure between treatment groups, defined as full epithelialization of the reference wound without drainage.
Time frame: From enrollment until 16 weeks
Frequency of subsequent procedures
Frequency of subsequent procedures (surgical debridement; minor/major amputation)
Time frame: From enrollment to 16 weeks
Vascular changes as measured by Ankle Brachial Index (ABI) measured as mmHg/mmHg
ABI and TcPO2 at 16 weeks and at 6, 9 and 12 months
Time frame: From enrollment to 16 weeks, 6, 9 and 12 months
Plasma growth factor level changes as measured by VEGf at 16 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
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Improvement in Visual Analog Scale to measure pain
Improvement in pain as measured in a 10 point VAS scale at 16 weeks
Time frame: From enrollment to 16 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)
Measuring oxygen pressure in the limb in mmHG
Time frame: Measured at baseline to 16 weeks
Vascular Perfusion measured by Computed Tomography Angiogram (CTA) at 16 weeks and at 6, 9 and 12 months
CTA is measured in Hounsfield Units (HU)
Time frame: Through 12 months
Improvement in Patient Reported Outcome Wound-QoL-17 at 16 weeks
Improvement in Quality of Life Measure Wound-QoL-17 at 16 weeks using a composite 100 point scale
Time frame: From enrollment to 16 weeks