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 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT02990832
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with diabetes mellitus according to definitions outlined by the American Diabetes Association
* Presenting with a localized mild infection of the ulcer as listed in the IDSA Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections (Table 1); exceeding 0.5 cm2 in area after appropriate debridement
* Diagnosis of mild infection must be confirmed immediately following debridement at Baseline
* Subject must agree to adhere to all protocol procedures and must be willing and able to provide written informed consent.
* Correction or optimization of underlying medical problems (e.g. diabetes or systemic infection).
* Wound has been identified as stalled or persistent non-healing under current standard-of-care; showing no progression in 2 weeks as per IDSA guidelines
Exclusion Criteria:
* Use of systemic antibiotics within the previous 2 weeks
* Known silver sensitivity
* Current use of enzymatic debridement
* Wounds where best practice wound bed preparation is not available or applicable (eg, wound with diminutive oxygen supply would be contraindicated for debridement.
* No palpable dorsalis pedis or posterior tibial pulse or a pedal systolic pressure (Doppler) of ≤ 40 mm Hg
* Evidence of systemic infection (fever, chills, hypotension)/sepsis
* Non-study systemic or anti-infective topical agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02990832
Study Brief:
Protocol Section:
NCT02990832