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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT02978560
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects, of any ethnic background, who are at least 21 years of age and have normal healthy skin (30 normal subjects) or patients with diabetic foot ulcer lesions (30 patients).
2. All subjects must be willing and be able to comply with the protocol, and to provide informed consent.
Exclusion Criteria:
1. Patient currently participating in any other drug or device investigational study.
2. Patient with significant liver or kidney disease.
3. Patient with known adverse reaction to indocyanine green or iodine.
4. Patient is pregnant or nursing.
5. Patient with peripheral vascular disease and an ankle-brachial index blood flow of 0.6 or less
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02978560
Study Brief:
Protocol Section:
NCT02978560