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:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT03044132
Eligibility Criteria:
Inclusion Criteria:
* Wagner Grade 3 or 4 complex soft tissue defect that extends below subcutaneous tissue (exposed fascia, ligament, tendon, muscle, or bone)
* target wound that is either acute or chronic (nonhealing wounds greater than 4 weeks but not greater than 1 year in duration)
* target wound that is not amendable to primary closure
* target wound deemed without any residual infection (as assessed by Investigator) or is being treated upon entry into the clinical trial
* adequate perfusion to the extremity
* laboratory assessments which represent a good potential for wound healing (liver and kidney function, nutritionally stable and diabetes control)
Exclusion Criteria:
* untreated infection of soft tissue or bone
* untreated autoimmune connective tissue disorders
* body mass index (BMI) of ≥ 50
* undergoing chemotherapy/radiation therapy or taking an immunosuppressant medication
* active liver disease (e.g. hepatitis A-G),
* have undergone previous wound care therapy that included any bioengineered alternative tissue or STSG 30 days prior to enrollment
* pregnant
* enrolled in any other interventional clinical research trial
* an increase or decrease of more than 25% in wound area or volume from the Screening to Baseline visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT03044132
Study Brief:
Protocol Section:
NCT03044132