Phototherapy ComplicationNCT05739058

Violet-Blue Light Inactivation of Bacteria in Chronic Wounds

A study testing Violet-Blue Light Treatment / FlashHeal Device in people with Phototherapy Complication and Photobiology, run by Bispebjerg Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Phototherapy Complication, Photobiology, Light Treatment; Complications
What is being tested?: Violet-Blue Light Treatment / FlashHeal Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteDenmark
Study dates: 22 Mar 2023to 1 May 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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 locations and contacts

1 site in 1 country.

Denmark1 site

Danish Wound Healing Center, Bispebjerg Hospital
Copenhagen, Northwest, 2400

Other trials in Denmark

About this study

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.

Read the 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

Conditions: Phototherapy Complication, Photobiology, Light Treatment; Complications, Wound Infection, Wound Heal
Being tested: Violet-Blue Light Treatment / FlashHeal Device
Keywords: Violet Blue Light, Blue Light, Safety
Medical subject headings: Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Violet-Blue Light Treatment / FlashHeal DeviceDevice
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.

Study groups in NCT05739058
Study group	Role	What they receive
Low Exposure to Violet-Blue Light	Experimental	ID 1-7 are assigned to the low dosage group Receives: Device: Violet-Blue Light Treatment / FlashHeal Device
Medium Exposure to Violet-Blue Light	Experimental	ID 8-15 are assigned to the medium dosage group Receives: Device: Violet-Blue Light Treatment / FlashHeal Device
High Exposure to Violet-Blue Light	Experimental	ID 16-22 are assigned to the high dosage group Receives: Device: Violet-Blue Light Treatment / FlashHeal Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 4 weeks

Secondary outcomes (27)

Baseline Clinical Wound Assessment
Evaluates wound symptoms (Exudate, necrosis, maceration, granulation, Oedema,) and skin symptoms (eczema, Erythema, Hyperpigmentation, Hypopogmentation, epthilializing) at a 4 step scale from none to mild, moderate, severe.
Measured: Baseline, 1 week
Clinical Wound Assessment
Evaluates wound symptoms (Exudate, necrosis, maceration, granulation, Oedema,) and skin symptoms (eczema, Erythema, Hyperpigmentation, Hypopogmentation, epthilializing) at a 4 step scale from none to mild, moderate, severe.
Measured: Pre-intervention, up to 3 weeks
Follow up Clinical Wound Assessment
Evaluates wound symptoms (Exudate, necrosis, maceration, granulation, Oedema,) and skin symptoms (eczema, Erythema, Hyperpigmentation, Hypopogmentation, epthilializing) at a 4 step scale from none to mild, moderate, severe.
Measured: Follow Up, up to 4 weeks
Numeric Rating Scale (1-10)
Pain scale in relation to treatment. Higher scores indicate more pain.
Measured: Post-intervention, up to 3 weeks
Wong Baker FACES (1-10)
Visual Pain scale in relation to treatment. Higher scores indicate more pain.
Measured: Post-intervention, up to 3 weeks
Investigator Questionnaire
Usability of the medical device is tested with the system usability Scale (SUS) testing 10 items on a 5 step scale from Strongly Disagree to Strongly Agree.
Measured: 4 weeks
Patient Questionnaire
Evaluating Participant perceived; pain, time consumption and satisfaction through 20 items.
Question 1-13 can be answered on a 5 step scale from "to a very high degree" till "not at all", including possibility to answer "dont know" and "not relevant".
Item 14-20 can be answered with "Yes", "No" and "Dont Know".
Measured: 4 weeks
Mean time of visit
Total time for the visit will be measured in minutes.
Measured: For every visit, up to 4 weeks
Mean time of Treatment Procedure
For every treatment visit, time used for the treatment with the FlashHeal Device is measured.
Time is measured in minutes.
Measured: Post-intervention, up to 3 weeks
Baseline Mean Bacterial Load
E-Swabs, Essen Rotary Technique performed at baseline, follow-up and before and after treatment with FlashHeal Device. Bacteria will be cultured for aerobe and anaerobe species.
Measured: 1 week
Pre-intervention Mean Bacterial Load
E-Swabs, Essen Rotary Technique performed at baseline, follow-up and before and after treatment with FlashHeal Device. Bacteria will be cultured for aerobe and anaerobe species.
Measured: Pre-intervention, up to 3 weeks
Post-intervention Mean Bacterial Load
E-Swabs, Essen Rotary Technique performed at baseline, follow-up and before and after treatment with FlashHeal Device. Bacteria will be cultured for aerobe and anaerobe species.
Measured: Post-intervention, up to 3 weeks
Mean Bacterial Load at Follow Up
E-Swabs, Essen Rotary Technique performed at baseline, follow-up and before and after treatment with FlashHeal Device. Bacteria will be cultured for aerobe and anaerobe species.
Measured: Follow up, up to 4 weeks
Baseline Wound Fluid
Swab for wound fluid performed once every week using the Essen Rotary Technique, testing for 6-10 cytokines assessing the inflammatory microenvironment.
Measured: Baseline, 1 Week
Change from Baseline Wound Fluid Composition Week 1 to Week 2
Swab for wound fluid performed once every week using the Essen Rotary Technique, testing for 6-10 cytokines assessing the inflammatory microenvironment.
Measured: 2 Weeks
Change from Baseline Wound Fluid Composition Week 1 to Week 3
Swab for wound fluid performed once every week using the Essen Rotary Technique, testing for 6-10 cytokines assessing the inflammatory microenvironment.
Measured: 3 Weeks
Change from Baseline Wound Fluid Composition Week 1 to Week 4
Swab for wound fluid performed once every week using the Essen Rotary Technique, testing for 6-10 cytokines assessing the inflammatory microenvironment.
Measured: 4 weeks
Baseline Wound Size Week 1
Clinical Photography is performed once every week. Hereafter the wound is analysed with the ImageJ software to calculate wound size in cm2.
Measured: Baseline, week 1
Change from Baseline Wound Size Week 1 to Week 2
Clinical Photography is performed once every week. Hereafter the wound is analysed with the ImageJ software to calculate wound size in cm2.
Measured: 2 Weeks
Change from Baseline Wound Size Week 1 to Week 3
Clinical Photography is performed once every week. Hereafter the wound is analysed with the ImageJ software to calculate wound size in cm2.
Measured: 3 Weeks
Change from Baseline Wound Size Week 1 to Week 4
Clinical Photography is performed once every week. Hereafter the wound is analysed with the ImageJ software to calculate wound size in cm2.
Measured: Follow Up, 4 weeks
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). The CTCAE is adjusted to the skin.
Measured: Post-intervention, 2 weeks
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). The CTCAE is adjusted to the skin.
Measured: 30 minutes Post-intervention, 2 weeks
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). The CTCAE is adjusted to the skin.
Measured: 24 hours Post-intervention, 2 weeks
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). The CTCAE is adjusted to the skin.
Measured: 48 hours Post-intervention, 2 weeks
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).
The CTCAE is adjusted to the skin.
Measured: 120 hours Post-intervention, 2 weeks
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).
The CTCAE is adjusted to the skin.
Measured: Follow Up, 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 20231 May 2024

First posted22 Feb 2023
Study start22 Mar 2023
Primary completion1 May 2024
Study completion1 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Phototherapy ComplicationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Device feasibility
Allocation: Non-randomised
Intervention model: Sequential
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.
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05739058
Sponsor's protocol ID: Violet-Blue-Light-Inactivation
Status last verified: May 2024
First submitted: 12 Jan 2023
Last updated: 3 May 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 18211573
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.
PubMed 28103163
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.
PubMed 24138170
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.
PubMed 34800566
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.
PubMed 29350751
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.
PubMed 33961502
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.
PubMed 23262998
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.
PubMed 29145971
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.
PubMed 19675580

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Phototherapy Complication trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Violet-Blue Light Inactivation of Bacteria in Chronic Wounds
ClinicalTrials.gov ID: NCT05739058
Acronym / sponsor ID: Violet-Blue-Light-Inactivation
Conditions: Phototherapy Complication, Photobiology, Light Treatment; Complications, Wound Infection, Wound Heal
Keywords: Violet Blue Light, Blue Light, Safety
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Bispebjerg HospitalUniversity, hospital or other
Collaborators: Hvidovre University Hospital, Copenhagen University Hospital, Rigshospitalet
Study start: 22 Mar 2023 (actual)
Primary completion: 1 May 2024 (actual)
Study completion: 1 May 2024 (actual)
First posted: 22 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Device feasibility
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3
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.

Arm	Type	Receives
Low Exposure to Violet-Blue Light	Experimental	Device: Violet-Blue Light Treatment / FlashHeal DeviceID 1-7 are assigned to the low dosage group
Medium Exposure to Violet-Blue Light	Experimental	Device: Violet-Blue Light Treatment / FlashHeal DeviceID 8-15 are assigned to the medium dosage group
High Exposure to Violet-Blue Light	Experimental	Device: Violet-Blue Light Treatment / FlashHeal DeviceID 16-22 are assigned to the high dosage group

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Violet-Blue Light Treatment / FlashHeal DeviceFlashHeal 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.	Device	High Exposure to Violet-Blue Light, Low Exposure to Violet-Blue Light, Medium Exposure to Violet-Blue Light

Primary outcome

Overall Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
Time frame: 4 weeks
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.

27 secondary outcomes

Baseline Clinical Wound Assessment
Time frame: Baseline, 1 week
Clinical Wound Assessment
Time frame: Pre-intervention, up to 3 weeks
Follow up Clinical Wound Assessment
Time frame: Follow Up, up to 4 weeks
Numeric Rating Scale (1-10)
Time frame: Post-intervention, up to 3 weeks
Wong Baker FACES (1-10)
Time frame: Post-intervention, up to 3 weeks
Investigator Questionnaire
Time frame: 4 weeks
Patient Questionnaire
Time frame: 4 weeks
Mean time of visit
Time frame: For every visit, up to 4 weeks
Mean time of Treatment Procedure
Time frame: Post-intervention, up to 3 weeks
Baseline Mean Bacterial Load
Time frame: 1 week
Pre-intervention Mean Bacterial Load
Time frame: Pre-intervention, up to 3 weeks
Post-intervention Mean Bacterial Load
Time frame: Post-intervention, up to 3 weeks
Mean Bacterial Load at Follow Up
Time frame: Follow up, up to 4 weeks
Baseline Wound Fluid
Time frame: Baseline, 1 Week
Change from Baseline Wound Fluid Composition Week 1 to Week 2
Time frame: 2 Weeks
Change from Baseline Wound Fluid Composition Week 1 to Week 3
Time frame: 3 Weeks
Change from Baseline Wound Fluid Composition Week 1 to Week 4
Time frame: 4 weeks
Baseline Wound Size Week 1
Time frame: Baseline, week 1
Change from Baseline Wound Size Week 1 to Week 2
Time frame: 2 Weeks
Change from Baseline Wound Size Week 1 to Week 3
Time frame: 3 Weeks
Change from Baseline Wound Size Week 1 to Week 4
Time frame: Follow Up, 4 weeks
Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
Time frame: Post-intervention, 2 weeks
Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
Time frame: 30 minutes Post-intervention, 2 weeks
Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
Time frame: 24 hours Post-intervention, 2 weeks
Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
Time frame: 48 hours Post-intervention, 2 weeks
Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
Time frame: 120 hours Post-intervention, 2 weeks
Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
Time frame: Follow Up, 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
Background: PubMed 18211573Bjarnsholt 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.
Background: PubMed 28103163Malone 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.
Background: PubMed 24138170Enwemeka 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.
Background: PubMed 34800566Leanse 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.
Background: PubMed 29350751Tomb 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.
Background: PubMed 33961502Plattfaut 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.
Background: PubMed 23262998Dai 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.
Background: PubMed 29145971Wang 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.
Background: PubMed 19675580Liebmann 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Frederik Plum, MD principal investigator

Danish Wound Healing Center, Bispebjerg Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Violet-Blue Light Treatment / FlashHeal Device in people with Phototherapy Complication and Photobiology, run by Bispebjerg Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05739058, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.