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 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
NCT ID:
NCT05748392
Eligibility Criteria:
Inclusion Criteria
* Subject is at least 22 years old at time of consent.
* Subject OR Legal Authorized Representative is able to provide informed consent.
* Subject has been confirmed to have a chronic, acute, traumatic, sub-acute, or dehisced wound, partial-thickness burn, ulcer (such as diabetic, pressure or venous insufficiency), flap or graft.
Exclusion Criteria:
* Subject is pregnant prior to application of the initial dressing\*
\*Women who have had surgical sterilization by a medically accepted method (i.e. tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for \> 12 months will not be required to undergo pregnancy testing.
* Subject has been diagnosed with a malignancy in the wound.
* Subject has untreated osteomyelitis.
* Subject has an untreated systemic infection.
* Subject has active cellulitis in the peri-wound area.
* Subject has a known allergy or hypersensitivity to study materials: dressing(s), and/or dressing components such as acrylic or silicone adhesives or polyurethane.
* Subject has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.
* Subject has had radiation directly to the wound area.
* Subject has been diagnosed with a major vascular deficit limiting arterial inflow to the wound region, as determined by the Investigator's interpretation of the Subject's medical history.
* Subject has necrotic tissue with eschar present. NOTE: After debridement of necrotic tissue and complete removal of eschar, Veraflo™ Therapy may be used.
* Subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days of Visit 1.
* Subject has non-enteric or unexplored fistula.
* Subject has a wound with any unexplored tunneling present.
* Subject has inadequate hemostasis at the wound site, as determined by the investigator.
* Subject has a wound with non-protected exposed vessels, anastomotic sites, organ, or nerves.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT05748392
Study Brief:
Protocol Section:
NCT05748392