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 @ 1:36 PM
Ignite Modification Date:
2025-12-24 @ 1:36 PM
NCT ID:
NCT03854695
Eligibility Criteria:
Inclusion Criteria:
* Ankle Brachial Index (ABI) ≥ 0.5 (bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to surgery)
* One or more chronic lower extremity wounds that are located in the ankle area or below that has persisted a minimum of 30 days prior to the Screening visit, however, only one wound per subject will be included.
* Ulcer grade I or II, Stage A-D, according to University of Texas Wound Classification System
* ≥21 years of age or older
* Diagnosis of diabetes mellitus
Exclusion Criteria:
* • Subject has major immunodeficiency
* Subject is human immunodeficiency virus (HIV)+
* Subject has untreated osteomyelitis
* Subject has active cellulitis
* Subject has active charcot
* Is pregnant or plans to become pregnant
* Is nursing or actively lactating
* Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years
* Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03854695
Study Brief:
Protocol Section:
NCT03854695