Violet-Blue Light Inactivation of Bacteria in Chronic Wounds

NCT05739058 | Completed DMC

• 1 other identifier: Violet-Blue-Light-Inactivation
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Violet Blue Light; Blue Light; Safety

Outcome Measures

Primary Outcomes (1)

• Overall Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)

  Safety is measured as the absence of Adverse Events (AE) skin reactions. Adverse event skin reactions are assessed with the Common Terminology Criteria for Adverse Events U.S Department of Health and Human Services version 5.0, Nov 27, 2017 (CTCAE) adjusted to the skin. The violet-blue light treatment will be considered safe when less than 30 % have an overall CTCAE score larger than Grade 2 CTCAE. The overall CTCAE score for each patient is based on the one CTCAE score with the most severe grading.

  4 weeks

Secondary Outcomes (27)

• Baseline Clinical Wound Assessment

  Baseline, 1 week

• Clinical Wound Assessment

  Pre-intervention, up to 3 weeks

• Follow up Clinical Wound Assessment

  Follow Up, up to 4 weeks

• Numeric Rating Scale (1-10)

  Post-intervention, up to 3 weeks

• Wong Baker FACES (1-10)

  Post-intervention, up to 3 weeks

Study Arms (3)

Low Exposure to Violet-Blue Light

EXPERIMENTAL

ID 1-7 are assigned to the low dosage group

Device: Violet-Blue Light Treatment / FlashHeal Device

Medium Exposure to Violet-Blue Light

EXPERIMENTAL

ID 8-15 are assigned to the medium dosage group

Device: Violet-Blue Light Treatment / FlashHeal Device

High Exposure to Violet-Blue Light

EXPERIMENTAL

ID 16-22 are assigned to the high dosage group

Device: Violet-Blue Light Treatment / FlashHeal Device

Interventions

Violet-Blue Light Treatment / FlashHeal Device DEVICE

FlashHeal illuminates an area of 10 cm in diameter, located at 6-7 cm distance of the wound. Wounds larger than 10 cm in diameter, will receive enough treatments to cover the wound bed. To obtain full coverage the circular treatment area is relocated to cover the remaining wound field. The wavelength is 405 nm, Full Width Half Maximum at (FWHM) 400-415 nm. Device irradiances are adjusted to the total fluences required for the Low, Medium and High group, the treatment will last 15 minutes at all dosages. Light is emitted with 1000 Hz.

High Exposure to Violet-Blue Light; Low Exposure to Violet-Blue Light; Medium Exposure to Violet-Blue Light

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants are included based on self-representation of gender identity, including non-binary self-representation.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Hvidovre University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Danish Wound Healing Center, Bispebjerg Hospital

Copenhagen, Northwest, 2400, Denmark

Location

Related Publications (9)

• 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.

  PMID: 18211573 BACKGROUND

• 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.

  PMID: 28103163 BACKGROUND

• Enwemeka CS. Antimicrobial blue light: an emerging alternative to antibiotics. Photomed Laser Surg. 2013 Nov;31(11):509-11. doi: 10.1089/pho.2013.9871. Epub 2013 Oct 18. No abstract available.

  PMID: 24138170 BACKGROUND

• Leanse LG, Dos Anjos C, Mushtaq S, Dai T. Antimicrobial blue light: A 'Magic Bullet' for the 21st century and beyond? Adv Drug Deliv Rev. 2022 Jan;180:114057. doi: 10.1016/j.addr.2021.114057. Epub 2021 Nov 18.

  PMID: 34800566 BACKGROUND

• Tomb RM, White TA, Coia JE, Anderson JG, MacGregor SJ, Maclean M. Review of the Comparative Susceptibility of Microbial Species to Photoinactivation Using 380-480 nm Violet-Blue Light. Photochem Photobiol. 2018 May;94(3):445-458. doi: 10.1111/php.12883. Epub 2018 Mar 31.

  PMID: 29350751 BACKGROUND

• 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.

  PMID: 33961502 BACKGROUND

• Dai T, Gupta A, Huang YY, Yin R, Murray CK, Vrahas MS, Sherwood ME, Tegos GP, Hamblin MR. Blue light rescues mice from potentially fatal Pseudomonas aeruginosa burn infection: efficacy, safety, and mechanism of action. Antimicrob Agents Chemother. 2013 Mar;57(3):1238-45. doi: 10.1128/AAC.01652-12. Epub 2012 Dec 21.

  PMID: 23262998 BACKGROUND

• Wang Y, Wang Y, Wang Y, Murray CK, Hamblin MR, Hooper DC, Dai T. Antimicrobial blue light inactivation of pathogenic microbes: State of the art. Drug Resist Updat. 2017 Nov;33-35:1-22. doi: 10.1016/j.drup.2017.10.002. Epub 2017 Oct 13.

  PMID: 29145971 BACKGROUND

• Liebmann J, Born M, Kolb-Bachofen V. Blue-light irradiation regulates proliferation and differentiation in human skin cells. J Invest Dermatol. 2010 Jan;130(1):259-69. doi: 10.1038/jid.2009.194.

  PMID: 19675580 BACKGROUND

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Frederik Plum, MD

  Danish Wound Healing Center, Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D Fellow at University of Copenhagen

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 22, 2023
• Study Start: March 22, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)