Transverse Tibial Bone Transport (TTT) In The Management Of Chronic Diabetic Lower Extremity Wounds
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 25-010727
NCT ID: NCT07444593
Sponsor Protocol Number: BD-TTT-001
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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
* Wounds less than 1 cm3 or greater than 30 cm3
* Corticosteroids >10mg prednisone equivalent daily for >2 weeks
* Patients with osteomyelitis in the ipsilateral tibia at planned corticotomy site
* 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 >12
* BMI <18.5 kg/m2
* Pregnant, lactating, or planning to become pregnant
* Life expectancy less than 12 months
* Severe hepatic impairment defined by patient on a transplant list, MELD > 20, 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.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 06/15/2026. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available