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 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT03903692
Eligibility Criteria:
Inclusion Criteria:
* Subject is able and willing to comply with requirements of this trial protocol
* Voluntarily signed informed consent before any trial related procedures are performed
* Subjects must be able to communicate effectively with study personnel
* Subject has lower extremity venous ulcer wound, as determined by site PI.
* Subject has adequate circulation as determined by biphasic or triphasic Doppler waveform, consistent with adequate blood flow, within three months prior to study enrollment. If monophasic on exam, then non-invasive tests must display Ankle Brachial Index over 0.8 and no worse than mild disease on segmental pressures.
* Subjects should not be allergic to silver (Ag).
* Size of subject's wound is between 1 squared centimeter and 100 squared centimeters.
* Duration of subject's wound is less than 52 weeks.
Exclusion Criteria:
* Subjects who are pregnant, nursing, or planning to become pregnant during the course of the study.
* Subjects who have known allergies to any ingredient(s) in the clinical products used in this study.
* Subjects who do not wish to use products derived from shellfish.
* Subjects with substance use disorder.
* Subjects with active infection or currently receiving antibiotic treatment.
* Subjects who are currently enrolled in another research study which includes investigational treatment and/or medication.
* Subjects judged by the investigator or sub-investigator to be inappropriate as a subject of this study.
* Subject has previous or current systemic disease(s) which, in the judgement of the site PI, is likely to interfere with the study. However, subjects with well-controlled diabetes mellitus (HbA1C \< 8.5) shall be permitted.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03903692
Study Brief:
Protocol Section:
NCT03903692