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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT02169167
Eligibility Criteria:
Inclusion Criteria:
* an adult patient (18-80 years) suffering from infected neuropathic fore- or mid-foot ulceration originated from type I or II diabetes (PEDIS-classification ≥ Grade II).
Exclusion Criteria:
* a patient whose life expectancy is less than 6 months
* an ulceration of ischemic or neuroischemic origin
* presence of systemic inflammatory response signs
* heel ulceration
* presence of osteomyelitis
* pregnancy
* known hypersensitivity to any of the ingredient including in the study or control treatment products
* a patient who is unable to give informed consent
* a patient who has an advanced malignant disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02169167
Study Brief:
Protocol Section:
NCT02169167