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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT06007703
Eligibility Criteria:
Inclusion Criteria:
* Related to the patient:
* Patient over 18 years old who has provided his/her written informed consent,
* Patient who is able and willing to commit to regular follow up with the investigating team for the purpose of the study, and in line with established service protocols for routine patient follow up until ulcer healed,
* Patient who agrees to adhere to the study protocol with respect to the type of multilayer compression system and primary wound dressing,
Related to the venous leg ulcer:
* Ulcer between 2 and 20 cm² in surface,
* Ulcer duration less than six weeks ("new ulcer"),
* Venous leg ulcer - Ankle Brachial Pressure Index \> 0.85 at baseline, done in the previous three months and if not, at the inclusion of the patient),
Exclusion Criteria:
Related to the patient:
* Patient participating in another clinical trial,
* Patient with known hypersensitivity to one of the components of the tested compression system Urgo KTwo Lite Latex free or the UrgoStart dressings,
* Patient who is unable to tolerate compression therapy,
* Patient presenting a neoplastic lesion treated by radiotherapy or chemotherapy or patients treated with immunosuppressive drugs or high-dose corticosteroids,
* Patient with a history of deep or superficial vein thrombosis in the 3 months prior to inclusion,
* Patient confined to bed.
Related to the leg ulcer:
* Ulcer with ABPI\<0.85,
* Ulcer which is clinically infected,
* Ulcer surface area partially or totally covered by black necrosis plaque,
* Malignant ulcer,
* Ulcer less than 3 cm, from any edge, to another wound located on the same limb.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06007703
Study Brief:
Protocol Section:
NCT06007703