Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07444593
Eligibility Criteria:
Inclusion Criteria:
* Adults (\>=22 years).
* Chronic lower extremity wound persisting \>=12 weeks and 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
* Corticosteroids \>10mg prednisone equivalent daily for \>2 weeks
* Patients with osteomyelitis in the ipsilateral tibia of the corticotomy
* 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
* Pregnant or planning to become pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT07444593
Study Brief:
Protocol Section:
NCT07444593