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 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT05739058
Eligibility Criteria:
Inclusion Criteria:
* Men, women and non-binaries fulfilling all inclusion criteria
* Age \>18 - Patients with a chronic wound defined \> 6 weeks
* Wound Area \> 1 cm and \< 25 cm
* Patient can understand Danish
* Patient can comply with protocol
* Patient is fully informed about the study and has given informed consent
Exclusion Criteria:
* Clinical infection in the wound requiring systemic or local antibiotics
* Current intake of antibiotics or locally applied (within 7 days before baseline)
* Known or suspected cancer in the wound
* Previous Photodermatitis and/or Photosensitivity
* Previous Porphyria and/or hypersensitivity to porphyrins
* Known congenital or acquired immunodeficiency
* Newly adjusted or newly started systemic immunomodulate treatment \>4 weeks
* Treatment with haemodialysis
* Dementia - Participating in other clinical wound healing studies in the last 30 days
* Judgement by the investigator that the patient is not suited for study participation
* Pregnant or breastfeeding women. (All fertile women who is not on safe contraception will need a negative pregnancy test performed at baseline. Safe contraception includes cobber and hormone Intra Uterine Device and Hormone anticonception drugs. Sterility is defined as have had surgical sterilisation and being postmenopausal)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05739058
Study Brief:
Protocol Section:
NCT05739058