Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds (NCT07444593) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds
United States100 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 impairmen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.