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 @ 4:40 PM
Ignite Modification Date:
2025-12-24 @ 4:40 PM
NCT ID:
NCT07170566
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects aged 18 years or older at the time the data were reported.
* Subjects with hard-to-heal wound(s), defined as those that have failed to show improvement (which is defined as ≥50% reduction in wound area) over 4-weeks of standard wound care.
* Initial Wound area that is \>0.5 cm2 and \<10 cm2
* InnovaMatrix® AC applied to target wound(s) for a minimum of two consecutive weekly visits inside a 4-week period.
* Subjects were compliant with wound protection strategies through treatment period (offloading, compression, etc).
* The target wound(s) is not undergoing active management at the time of data entry.
Exclusion Criteria:
* Wound area showed ≥50% reduction in 4-weeks preceding initial InnovaMatrix® AC application.
* Cases where InnovaMatrix® AC was not applied at a minimum of two consecutive weekly visits inside a 4-week period.
* Subjects who were non-compliant with additional wound protection strategies (offloading, compression, etc)
* Subjects with severe comorbidities that significantly impact healing ability, or ability for subject to be compliant with wound protection strategies, such as: peripheral vascular disease (ABI \<0.4, \>1.3)1, severely uncontrolled diabetes (Hgb A1C \>9.0%), neurodegenerative disorders, Charcot foot, high dose corticosteroid or other immunosuppressant, etc
* Wound area \<0.5 cm2 or \>10 cm2
* The target wound is still under active treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT07170566
Study Brief:
Protocol Section:
NCT07170566