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 @ 4:05 AM
Ignite Modification Date:
2025-12-25 @ 4:05 AM
NCT ID:
NCT01646502
Eligibility Criteria:
Inclusion Criteria:
1. Have a leg ulcer with the ankle brachial pressure index (ABPI) equal or greater than 0.6;
2. Have a wound that is 15 cm or less in diameter;
3. Are 19 years or older;
4. Have no known contraindication to the treatment products
Exclusion Criteria:
1. Have a leg ulcer caused by pressure, diabetes, ischemia, inflammatory disorder, hematologic disorder or malignancy
2. Have applied an antiseptic to the wound in the one week prior to recruitment
3. Have received systemic or topical antibiotic therapy within 48 hours prior to recruitment
4. Are being treated with systemic steroids (prednisone)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT01646502
Study Brief:
Protocol Section:
NCT01646502