Violet-Blue Light Inactivation of Bacteria in Chronic Wounds

Bispebjerg Hospital

Status: Completed

Conditions: Phototherapy Complication; Light Treatment; Complications; Wound Heal; Photobiology; Wound Infection

Treatments: Device: Violet-Blue Light Treatment / FlashHeal Device

Study type: Interventional

Funder types: Other

Identifiers

NCT05739058

Violet-Blue-Light-Inactivation

Details and patient eligibility

About

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.

Full description

This is as prospective safety and feasibility clinical trial investigating violet-blue light treatment on chronic wounds. This clinical trial runs from Q3 2022 - Q2 2023. Twenty-two patients with chronic wounds will be included (n = 22) for a study-period of four weeks. Week 1 includes one baseline visit. Through Week 2,3 and 4 treatment is given six times with a span of 24-72 hours between every treatment visit. Week 4 includes one follow up-visit. Patients entering the study are assigned to three light dosage groups (low, medium and high) according to their study ID. 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. Between each dosage of light, there will be an evaluation of primary and secondary endpoints by the sponsor and the principal investigator. Light dosage is only escalated should this evaluation be deemed safe. To determine treatment safety skin reactions are assessed after treatment at: 0 minutes, 30 minutes, 24 hours, 48 hours, 5th treatment visit and at follow-up. Adverse Events and Adverse Device Events are evaluated at every visit for every dosage, feasibility is evaluated at follow-up for both patient and investigator. This investigation complies with the Good Clinical Practice concerning medical devices and follows the ISO standard DS/EN 14 155 and the Declaration of Helsinki

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

Low Exposure to Violet-Blue Light

Experimental group

Description:

ID 1-7 are assigned to the low dosage group

Treatment:

Device: Violet-Blue Light Treatment / FlashHeal Device

Medium Exposure to Violet-Blue Light

Experimental group

Description:

ID 8-15 are assigned to the medium dosage group

Treatment:

Device: Violet-Blue Light Treatment / FlashHeal Device

High Exposure to Violet-Blue Light

Experimental group

Description:

ID 16-22 are assigned to the high dosage group

Treatment:

Device: Violet-Blue Light Treatment / FlashHeal Device