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 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 1:35 AM
NCT ID:
NCT02138994
Eligibility Criteria:
Inclusion Criteria:
* Male or female 18 years or older
* Presence of full-thickness wound for more than one month (i.e. chronic)
* Ulcer must be greater than 1 centimeter in area to enable biofilm sampling
* NOT a candidate for vascular reconstructive surgery to restore blood flow to the wound
* Willing to comply with all study procedures and be available for the duration of the study
* Provide signed and dated informed consent
Exclusion Criteria:
* Subjects unable to provide signed and dated informed consent
* Male or female less than 18 years old
* Presence of a full-thickness wound for less than one month
* A candidate for vascular reconstructive surgery to restore blood flow to the wound
* Subjects with bleeding dyscrasia or with medical conditions that would make a bleeding complication likely
* Subjects who's wound is less than 1 cm precluding adequate wound biofilm sampling
* Subject with known allergic reaction to the study products
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02138994
Study Brief:
Protocol Section:
NCT02138994