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 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT05873257
Eligibility Criteria:
Inclusion Criteria:
1. Has signed informed consent
2. Is 18 years or above
3. Is capable of following study procedure (assessed by the investigator).
4. Has a venous leg ulcer that has failed to progress along the expected wound healing trajectory within 4 weeks
5. The shape of the wound should be possible to fit under a 10x10 cm dressing
6. The shape and location of the wound should be suitable for photo capture (assessed by the investigator).
7. Has at least three of five pre-defined clinical signs of infection; pain between two dressing changes, peri-ulcer skin erythema/inflammation, oedema, malodour, or heavy exudate (assessed by the investigator).
8. Has a wound that has medium to high level of exudate (assessed by the investigator).
9. Has an ankle to brachial pressure index (ABPI) of 0.8 -1.3
10. Agrees to wear compression therapy daily in combination with the test dressing
11. Is suitable to use the test product for wound treatment (assessed by the investigator).
Exclusion Criteria:
1. Is pregnant/breastfeeding
2. Wound is older than 12 months
3. Wound with exposed tendons or bones or has fistulas
4. Wound which is undermined or tunneling
5. Is currently receiving or has within the past 60 days received radio- and/or chemotherapy (low doses radio- and/or chemotherapy is allowed for other indications than cancer if assessed by investigator not to influence study wound area)
6. Known history of skin sensitivity to any components of the treatment dressings
7. Intake of antibiotics within one week before the start of the enrolment
8. Participation in any other clinical studies that can compromise this study treatment (assessed by the investigator).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05873257
Study Brief:
Protocol Section:
NCT05873257