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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT03790202
Eligibility Criteria:
Inclusion Criteria:
* male or female consenting and able patients aged 18 or more affiliated to social security
* presenting with acute or chronic traumatic or surgical lower limb wounds (excluding tumoral excision)
* presenting with no intercurrent pathology which in the opinion of the investigator may interfere with the capacity for wound healing
* patients whose wound is compatible in terms of location with VistaCare treatment
* patient whose wound has a minimal surface of 10 cm2
* patient whose wound does not need surgical Peterson after inclusion (if needed should be performed prior to inclusion)
Exclusion Criteria:
* Female patients pregnant, lactating, or of childbearing age and not using adequate contraception (pregnancy test mandatory)
* patients incapable of making an informed decision about participation
* patients presenting a condition that interferes with adequate wound healing capacity (uncontrolled diabetes, heavy smokers, auto-immune disease)
* concurrent treatment or treatment within one month prior to inclusion with local or systemic corticosteroids, immunosuppresseurs, chemotherapy or radiotherapy
* wound location incompatible with VistaCare
* general infection signs at the time of inclusion (fever, lymphangitis, pus ...)
* patients presenting with important uncontrolled hemorrhage at the time of inclusion
* patients previously recruited into this trial or any other trial within 1 month, or currently in the exclusion timeframe of another trial
* patients with a wound surface less than 10 cm2
* patient with a would previously treated with hyperbaric chamber
* legally incapacitated, under guardianship or psychiatric patients
* emergency condition prohibiting adequate patient consent prior to inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03790202
Study Brief:
Protocol Section:
NCT03790202