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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT02921750
Eligibility Criteria:
Inclusion Criteria:
1. Provision of informed consent i.e. subject must be able to understand and sign the Patient Information and Consent Form
2. Both gender ≥18 years old
3. Ulcer moderately or strongly exudative justifying the use of an absorbent dressing
4. (History of compression at least two weeks before inclusion) Deleted in Am.2
5. (Wound covered with slough ≥70%) Deleted in Am.4
6. 0.7≤ABPI\<1.3
7. Ulcer duration 6 weeks to 60 months
8. Ulcer size 3 cm2-100 cm2
9. Target ulcer at least 3 cm away from any other lesion
Exclusion Criteria:
1. Known allergy/hypersensitivity to the dressings
2. Pregnant or breastfeeding
3. Circumferential wounds (the entire wound should be able to be captured on a single image/photo)
4. Subjects who will have problems following the protocol
5. Subjects included in other ongoing clinical investigation evaluating wound dressings at present or during the past 30 days
6. Patient with a systemic infection not controlled by suitable antibiotic treatment
7. Clinically infected wound according to the judgement of the investigator (heat, pain, swelling, redness or purulent secretion)
8. Wound covered with black necrosis
9. Dry wounds
10. Malignant wound degeneration
11. Current treatment with radiotherapy, chemotherapy, immunosuppressant drugs or high doses of oral corticosteroids if any
12. Subject with deep vein thrombosis within 3 months prior to inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02921750
Study Brief:
Protocol Section:
NCT02921750