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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT02373956
Eligibility Criteria:
Inclusion Criteria:
* Information provided on the implementation of the study, its objectives, constraints and patient rights
* The patient, or his/her legal guardian, must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 weeks of follow-up
* Presence of one or more pressure ulcers at stages 2, 3 or 4 according to the European Pressure Ulcer Advisory Panel - National Pressure Ulcer Advisory Panel (EPUAP-NPUAP) classification
* Wound whose surface is between 1 cm\^2 and 15 cm\^2
* Wound present for more than 6 weeks
* Patient whose wound requires a modern dressing (that is to say, a bandage that is neither tulle nor gauze) without bactericidal agents or antibiotics
* No antibiotics for at least 7 days prior to inclusion (after inclusion, the patient can be treated with antibiotics if necessary, regardless of the indications)
Exclusion Criteria:
* Patient participating in or having participated in another interventional study in the previous 3 months or currently in a patient exclusion period determined by a previous study.
* Patient under judicial protection
* Failure to correctly inform the patient or his/her legal representative
* Patient (or his/her legal guardian) refusal to sign the consent
* The patient is pregnant, parturient, or breastfeeding
* Contraindications (or incompatible combination therapy) for a necessary treatment in this study
* Patient with an allergy to honey or propolis
* The patient's general condition suggests study exclusion before twelve weeks of follow-up
* Antibiotics received within 7 days prior to inclusion
* Active neoplastic lesion treated with radiation or chemotherapy
* Immunosuppressive therapy or other treatment which, in the judgment of the investigator, may interfere with the healing process
* Surgery planned within twelve weeks of inclusion
* Stage 1 wound according to the EPUAP-NPUAP classification
* Amputation wound
* Wound related to a surgical treatment or for which an act of revascularization is envisaged within twelve weeks of inclusion
* Malignant wound
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02373956
Study Brief:
Protocol Section:
NCT02373956