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:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT04593693
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects ≥18 years of age.
* Signed, informed consent by patient or LAR
* Patient is determined to be in need of NPWT for treatment of a diabetic foot ulcer, pressure injuries, and pressure ulcer, surgical wounds, acute/traumatic wounds and dehisced wounds, abscesses, or to prepare the wound bed for grafting or closure and/or to decrease edema
* Patient is comfortable (e.g. not in pain)
* Patient is willing and able to adhere to treatment protocol.
Exclusion Criteria:
* Patient not willing to comply with follow up (f/u) clinic visits
* Subjects with
* Necrotic tissue with eschar present
* Untreated osteomyelitis
* Non-enteric and unexplored fistulas
* Malignancy in wound
* Exposed vasculature
* Exposed nerves
* Exposed anastomotic site of blood vessels or bypasses
* Exposed organs
* Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
* Patients with concurrent conditions or co-morbidities that in the opinion of the investigator may compromise patient safety or study objectives
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04593693
Study Brief:
Protocol Section:
NCT04593693