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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT06978569
Eligibility Criteria:
Inclusion Criteria:
* Chronic trauma wounds persisting ≥3 weeks.
* Wound size between 4 and 20 cm² and depth ≤9 mm on the lower limbs.
* Willingness and ability to provide informed consent.
* Wounds without uncontrolled infection
Exclusion Criteria:
* Wounds with exposed bone.
* Current use of immunomodulators, corticosteroids, immunosuppressive or cytotoxic drugs.
* Pregnant individuals.
* Significant reduction (≥30%) of wound size during a 2-week run-in phase.
* Concurrent participation in another clinical trial involving drugs.
* Wounds with uncontrolled infection
* Allergy or hypersensitivity to components of ADM gel or alginate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06978569
Study Brief:
Protocol Section:
NCT06978569