Clinical trial NCT05739058: Violet-Blue Light Inactivation of Bacteria in Chronic Wounds
Official title: Violet-Blue Light Inactivation of Bacteria in Chronic Wounds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phototherapy Complication
Photobiology
Light Treatment; Complications
Wound Infection
Wound Heal
Keywords: Violet Blue Light
Blue Light
Safety
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
name: Rigshospitalet, Denmark
First posted: 2023-02-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This four-week prospective clinical investigation will assess the safety and feasibility of a medical device emitting LED violet-blue light. 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.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed 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

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)

Primary outcomes:
measure: Overall Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
timeFrame: 4 weeks
Secondary outcomes:
measure: Baseline Clinical Wound Assessment
timeFrame: Baseline, 1 week
measure: Clinical Wound Assessment
timeFrame: Pre-intervention, up to 3 weeks
measure: Follow up Clinical Wound Assessment
timeFrame: Follow Up, up to 4 weeks
measure: Numeric Rating Scale (1-10)
timeFrame: Post-intervention, up to 3 weeks
measure: Wong Baker FACES (1-10)
timeFrame: Post-intervention, up to 3 weeks
measure: Investigator Questionnaire
timeFrame: 4 weeks
measure: Patient Questionnaire
timeFrame: 4 weeks
measure: Mean time of visit
timeFrame: For every visit, up to 4 weeks
measure: Mean time of Treatment Procedure
timeFrame: Post-intervention, up to 3 weeks
measure: Baseline Mean Bacterial Load
timeFrame: 1 week
measure: Pre-intervention Mean Bacterial Load
timeFrame: Pre-intervention, up to 3 weeks
measure: Post-intervention Mean Bacterial Load
timeFrame: Post-intervention, up to 3 weeks
measure: Mean Bacterial Load at Follow Up
timeFrame: Follow up, up to 4 weeks
measure: Baseline Wound Fluid
timeFrame: Baseline, 1 Week
measure: Change from Baseline Wound Fluid Composition Week 1 to Week 2
timeFrame: 2 Weeks
measure: Change from Baseline Wound Fluid Composition Week 1 to Week 3
timeFrame: 3 Weeks
measure: Change from Baseline Wound Fluid Composition Week 1 to Week 4
timeFrame: 4 weeks
measure: Baseline Wound Size Week 1
timeFrame: Baseline, week 1
measure: Change from Baseline Wound Size Week 1 to Week 2
timeFrame: 2 Weeks
measure: Change from Baseline Wound Size Week 1 to Week 3
timeFrame: 3 Weeks
measure: Change from Baseline Wound Size Week 1 to Week 4
timeFrame: Follow Up, 4 weeks
measure: Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
timeFrame: Post-intervention, 2 weeks
measure: Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
timeFrame: 30 minutes Post-intervention, 2 weeks
measure: Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
timeFrame: 24 hours Post-intervention, 2 weeks
measure: Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
timeFrame: 48 hours Post-intervention, 2 weeks
measure: Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
timeFrame: 120 hours Post-intervention, 2 weeks
measure: Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
timeFrame: Follow Up, 4 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Wound Healing Center, Bispebjerg Hospital
state: Northwest
Study officials:
affiliation: Danish Wound Healing Center, Bispebjerg Hospital
name: Frederik Plum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjarnsholt T, Kirketerp-Moller K, Jensen PO, Madsen KG, Phipps R, Krogfelt K, Hoiby N, Givskov M. Why chronic wounds will not heal: a novel hypothesis. Wound Repair Regen. 2008 Jan-Feb;16(1):2-10. doi: 10.1111/j.1524-475X.2007.00283.x.
citation: Malone M, Bjarnsholt T, McBain AJ, James GA, Stoodley P, Leaper D, Tachi M, Schultz G, Swanson T, Wolcott RD. The prevalence of biofilms in chronic wounds: a systematic review and meta-analysis of published data. J Wound Care. 2017 Jan 2;26(1):20-25. doi: 10.12968/jowc.2017.26.1.20.
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citation: Plattfaut I, Demir E, Fuchs PC, Schiefer JL, Sturmer EK, Bruning AKE, Oplander C. Characterization of Blue Light Treatment for Infected Wounds: Antibacterial Efficacy of 420, 455, and 480 nm Light-Emitting Diode Arrays Against Common Skin Pathogens Versus Blue Light-Induced Skin Cell Toxicity. Photobiomodul Photomed Laser Surg. 2021 May;39(5):339-348. doi: 10.1089/photob.2020.4932.
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