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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT06652360
Eligibility Criteria:
Inclusion Criteria:
* Participants with a venous leg ulcer or mixed aetiology ulcer.
* Duration of wound ≥ 6 weeks ≤ 5 years
* Wound is ≥ 5 cm2 ≤ 200cm2
* Presence of at least 25% visible slough within the wound bed
* The Participant must be able to understand the study and provide written informed consent
* No clinical signs of infection
Exclusion Criteria:
* Known hypersensitivity or contraindications to any of the wound treatments, dressings or compression bandaging to be used in the trial
* Current local or systemic antibiotics in the week prior to inclusion
* Clinically infected wound as determined by the presence of 3 or more of the following clinical signs: perilesional erythema, pain between two dressing changes, malodorous wound, abundant exudate and oedema
* Prolonged treatment with immunosuppressive agents or high dose corticosteroids
* Participants who have a current illness or condition which may interfere with wound healing in the last 30 days (carcinoma, connective tissue disease, autoimmune disease or alcohol or drug abuse)
* Participants who have participated in a clinical trial on wound healing within the past month
* Participants with a known history of non- adherence with medical treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06652360
Study Brief:
Protocol Section:
NCT06652360