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:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT06063694
Eligibility Criteria:
Inclusion Criteria:
* Undergoing TMA
* At least 18 years old
* Adequate perfusion demonstrated by either TcPO2 or ankle-brachial index (ABI) or toe-brachia index (TBI) within 60 days prior to enrollment/randomization (Dorsum TcPO2 of study leg(s) ≥40mmHg OR ABI of study leg(s) with results of ≥ 0.7 and ≤ 1.3 OR TBI of study extremity(ies) with results of ≥ 0.5).
* Patient is willing and capable of complying with all protocol requirements.
* Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to any study procedures
Exclusion Criteria:
* Previously enrolled into this study or is currently participating in another prospective drug or device study that has not reached its primary endpoint.
* Patient is pregnant, breast feeding or planning to become pregnant.
* Patient has a known allergy to resorbable suture materials.
* Patient has a life expectancy less than three months as assessed by the investigator.
* Patient has received skin substitutes during the run-in period or within 14 days prior to beginning of run-in period.
* Patient currently undergoing cancer treatment.
* Patient diagnosed with autoimmune connective tissue.
* Patient is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the run-in period or up to 30 days before the run-in period.
* Chronic oral steroid use is not excluded if dose is \<10 mg per day for prednisone.
* Patient unwilling or unable to safely utilize appropriate offloading device to unweight wound(s).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06063694
Study Brief:
Protocol Section:
NCT06063694