Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds

Ki vehet részt

• 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

Ki nem vehet részt

• Corticosteroids >10mg prednisone equivalent daily for >2 weeks
• TNF-inhibitors or JAK inhibitors or chemotherapy-dose methotrexate
• Current participation in another investigational study (drug or device)
• Active systemic infection (positive blood cultures)
• End Stage Renal Disease requiring dialysis
• 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)
• 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
• Immunocompromised (WBC <4) or undergoing active chemotherapy
• Hemoglobin A1c >10
• 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
• 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
• Patients with osteomyelitis in the ipsilateral tibia at planned corticotomy site
• Cognitive or social limitations precluding consent or follow-up
• BMI <18.5 kg/m2
• Pregnant, lactating, or planning to become pregnant
• Life expectancy less than 12 months