Diabetic Foot UlcerChronic Ulcers of the Lower Limb
Investigational drug(s) / intervention(s)
Biodynamik XT3
Biodynamik XT3: Application of XT3 system and transverse tibial bone transport procedure
Study summary
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.
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Proportion of subjects with wound closure — From enrollment to 18 weeks 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.
Trial sites (1)
Facility
City
Region
Status
Mayo Clinic
Jacksonville
Florida
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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