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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT02583958
Eligibility Criteria:
Inclusion Criteria:
* Patient over 18 years old who has provided his/her written informed consent,
* Patient who can be monitored by the same investigation team throughout the whole duration of the study,
* Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing,
* Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3,
* Ulcer area \> or equal to 5cm2,
* Ulcer duration \> or equal to 6 months,
* Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue,
* Moderately or heavily exudative ulcers.
Exclusion Criteria:
* Clinical infection on the wound bed.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02583958
Study Brief:
Protocol Section:
NCT02583958