Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds
Purpose
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.
Conditions
- Diabetic Foot Ulcer
- Chronic Ulcers of the Lower Limb
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Standard of Care (control) |
Standard Wound Care |
|
|
Experimental Standard Wound Care plus TTT |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Biodynamik, Inc
Detailed Description
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.