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 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT05217160
Eligibility Criteria:
Inclusion Criteria:
1. Subjects age 18 or older able to provide informed consent.
2. Ulcer size 1-300 cm2
4\. Undermining/tunneling \<3 cm from wound margin 5. Grossly free of necrotic and/or infected tissue 6. Baseline minimum of 2 on VAS pain scale
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from the study:
1. Known allergy to the standard of care or any of the ingredients in KeraStat® Gel or to morphine
2. Wound has heavy or high-volume exudate or necrotic tissue
3. Clinical signs of infection or contamination of the wound
4. Subjects unable to complete the VAS pain score in pain journal
5. Pregnant or nursing
6. Prisoner
7. Any condition the Investigator determines will compromise subject safety or prevent the subject from completing the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05217160
Study Brief:
Protocol Section:
NCT05217160