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 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT05581966
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years old.
* Subject has an ulcer, or a slow healing wound that is full thickness for at least 4 weeks, below the malleolus, in the presence of Diabetes.
* The target ulcer will be the largest ulcer if two or more eligible DFUs are present and will be the only one evaluated in the study.
* The target ulcer is planned to undergo standard wound care (SWC) therapy (See 8.6 Standard Wound Care (SWC) Therapy).
* Subject understands and is willing to participate in the clinical study and can comply with required visits.
Exclusion Criteria:
* Target ulcer is deemed by the investigator to be caused by a medical condition other than diabetes.
* Target ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
* Eligible DFU has associated untreated acute osteomyelitis or active infection
* Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids \>10mg daily dose), or cytotoxic chemotherapy.
* Subjects on any investigational drug(s) or device(s) within 30 days preceding initial study visit.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05581966
Study Brief:
Protocol Section:
NCT05581966