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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT03181568
Eligibility Criteria:
Inclusion Criteria:
1. age ≥ 18 years
2. having a chronic wound that is not a diabetic foot ulcer
3. presence of the wound for ≥ 6 weeks and ≤ 2 years.
4. wound size surface area ≥ 2 cm2 and ≤ 50 cm2.
5. Willingness to comply with prescribed wound care regimen
Exclusion Criteria:
1. candidate for surgery in the next 12 weeks
2. a wound with necrotic tissue unable to tolerate debridement
3. uncontrolled diabetics (defined as HbA1c of \>85.5mmol/mol)
4. presence of a diabetic foot ulcer
5. currently taking medication that may interfere with wound healing (e.g., oral systemic steroids, immunosuppressive drugs, unfractionated heparin infusion)
6. women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control
7. participation in another investigative drug or device trial currently or within the last 30 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03181568
Study Brief:
Protocol Section:
NCT03181568