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 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
NCT ID:
NCT03112395
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Male and female patients
* Age: 18 - 90
* Chronic wound (venous ulcer, arterial ulcer, mixed ulcer) since at least 4 weeks
* Wound area minimal 1 cm2, maximal 50 cm2
* No adaptions for treatment of causal therapy of disease
Exclusion Criteria:
* Women who are pregnant
* Known or suspected non-compliance, drug or alcohol abuse,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* Patients with active devices (e.g. Pacemakers and defibrillators, infusion devices, insulin pumps)
* Metallic implants and endoprosthesis at extremities lower than hip
* Life threatening condition
* Immunosuppressive after foreign organ transplant or chemotherapeutic treatment within 30 days before study begin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03112395
Study Brief:
Protocol Section:
NCT03112395