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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT01125735
Eligibility Criteria:
Inclusion Criteria:
* Subject is at least 18 years or older.
* Subject has a chronic non healing wound located below the knee.
* Subject's wound is 5 cm2 or larger
* Subject's wound is adequately vascularized, demonstrated by SOC Doppler assessment.
* Subject must sign an institutional review board (IRB) approved informed consent.
* Subject is willing and able to complete required follow up.
* Subject's wound has been present longer than 30 days without 50% reduction in surface area in previous 30 days.
OR
* Subject's wound presents with acute gangrene or massive tissue loss that does not meet the 30 day criteria.
Exclusion Criteria:
* Subject's wound requires the use of topical antibiotics at the time of study enrollment.
* subject's wound presents with a malignancy in the wound bed.
* Subject has a cardiac pacemaker or other electronic device implants.
* Subject has a disorder or situation that the investigator believes will interfere with study compliance.
* Subject is currently enrolled or enrolled in the last 30 days in another investigational device or drug trial.
* Subject is pregnant or pregnancy is suspected.
* Subject's wound is smaller than 5cm2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01125735
Study Brief:
Protocol Section:
NCT01125735