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 @ 1:13 AM
Ignite Modification Date:
2025-12-25 @ 1:13 AM
NCT ID:
NCT04123093
Eligibility Criteria:
Inclusion Criteria:
Group 1: Subjects must meet all of the following criteria to be eligible for enrollment:
1. Subject is ≥ 18 and \< 80 years of age.
2. Subject is white, black or African American
3. Subject has provided written informed consent.
4. Subject is willing to comply with study follow-up requirements.
5. Subject has intact skin on lower extremities.
Group 2: Subjects must meet all of the following criteria to be eligible for enrollment:
1. Subject is ≥ 18 and \< 80 years of age.
2. Subject has a baseline wound surface area of \< 25 cm2.
3. Subject has provided written informed consent.
4. Subject is willing to comply with study follow-up requirements.
5. Subject with at least one of the following:
1. Diabetic lower extremity ulceration with a hemoglobin A1c (HgbA1c) value ≤ 9.0, drawn within 3 months prior to study participation , and/or
2. Arterial insufficiency lower extremity ulceration with a post-revascularization ankle-brachial index (ABI) value of ≥ 0.40 and ≤ 0.80 on the involved extremity, performed within 3 months prior to study participation1, and/or
3. Diabetic and/or arterial insufficiency lower extremity ulceration deemed in-eligible for revascularization with 3 months prior to study participation
Exclusion Criteria:
Group 1: Subjects will be excluded from the trial if any of the following criteria are met:
1. Subject is \< 18 or ≥ 80 years of age.
2. Subject has a history of diabetes, arterial insufficiency, or osteomyelitis.
3. Subject has a known hypersensitivity to adhesives.
4. Subject is on any prescription medications, including contraceptives. Due to the short duration of the procedure period (3 days), subjects who initiate prescription medications during study participation will continue in the study.
5. Subject is pregnant, plans to become pregnant during the study period, or is breastfeeding.
6. Subject is non-English speaking or reading.
7. Subject is unable to give informed consent. -
Group 2: Subjects will be excluded from the trial if any of the following criteria are met:
1. Subject is \< 18 or ≥ 80 years of age.
2. Subject has a baseline wound surface area of ≥ 25 cm2.
3. Subject has a plantar wound.
4. Subject with diabetes with an HgbA1c value of \> 9.0, drawn within 3 months prior to study participation . Subject with arterial insufficiency with an ABI value of \< 0.40 or \> 0.80, performed within 3 months prior to study participation .
5. Subject with osteomyelitis contiguous with the ulceration treatment site.
6. Subject with peripherally-inserted central catheter (PICC) line antibiotic treatment within the previous 6 months.
7. Subject requiring any type of amputation on the treatment limb within 3 months prior to study participation.
8. Subject with a known hypersensitivity to adhesives.
9. Subject is on active steroid therapy (does not include inhaled steroids).
10. Subject is pregnant, plans to become pregnant during the study period, or is breastfeeding.
11. Subject is non-English speaking or reading.
12. Subject is unable to give informed consent.
13. Subject is currently enrolled in another interventional study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT04123093
Study Brief:
Protocol Section:
NCT04123093