Violet-Blue Light Inactivation of Bacteria in Chronic Wounds

This four-week prospective clinical investigation will assess the safety and feasibility of a medical device without CE-marking. The medical device is a light-emitting-diode (LED) and is manufactured by VulCur MedTech Aps. Violet-blue light treatment is tested on a total of twenty-two patients with chronic wounds, divided into three groups, each group only receiving one dosage. Three dosages (low, medium and high) of violet-blue light treatment is tested. ID 1-7 are assigned to the low group, ID 8-15 are assigned to medium group and ID 16-22 are assigned to the high dosage group.

Inclusion Criteria:Men, women and non-binaries fulfilling all inclusion criteriaAge >18 - Patients with a chronic wound defined > 6 weeksWound Area > 1 cm and < 25 cmPatient can understand DanishPatient can comply with protocolPatient is fully informed about the study and has given informed consentExclusion Criteria:Clinical infection in the wound requiring systemic or local antibioticsCurrent intake of antibiotics or locally applied (within 7 days before baseline)Known or suspected cancer in the woundPrevious Photodermatitis and/or PhotosensitivityPrevious Porphyria and/or hypersensitivity to porphyrinsKnown congenital or acquired immunodeficiencyNewly adjusted or newly started systemic immunomodulate treatment >4 weeksTreatment with haemodialysisDementia - Participating in other clinical wound healing studies in the last 30 daysJudgement by the investigator that the patient is not suited for study participationPregnant 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)