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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT02458859
Eligibility Criteria:
Inclusion Criteria:
* Patients \>18 years old
* Males and females. If female, they must not be pregnant or lactating. If female and of reproductive age, a pregnancy test will be provided.
* The patient or their legal representative (if the patient is incapable of giving legal consent), is able to understand the trial and is willing to consent to the trial.
* Patients with sub-acute or chronic wounds (diabetic foot ulcer, pressure ulcer, venous leg ulcer, or other chronic) suitable for treatment with a PICO dressing.
* Wound duration ≤52 weeks - Amended to remove criteria.
* Wound area range ≥5 cm2 at start of screening period
* Wound maximum linear dimension ≤ 15cm
* Able to use English for the interview
Exclusion Criteria:
* Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing).
* Wounds which have an infection which is not being treated with systemic antibiotics.
* Wounds which are actively bleeding.
* Exposure of blood vessels, organs, bone or tendon at the base of the reference wound
* Exclude undermining or tunnelling present or suspected in the wound
* Use of negative pressure device on wound in the last 30 days. Amended to remove criteria
* Malignant wounds/malignancy in the wound
* Systemic infection not being treated with systemic antibiotics
* Simultaneous treatment with other experimental wound care procedures, biologics or devices
* Patients with a known history of poor compliance with medical treatment.
* Patients who have participated in this trial previously and who closed or were withdrawn.
* Patients who are unable to understand the aims and objectives of the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02458859
Study Brief:
Protocol Section:
NCT02458859