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Completed

NCT Number: NCT05739058

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Wound Healing Center, Bispebjerg Hospital

Copenhagen, Northwest, 2400, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Baseline Clinical Wound Assessment

    Time frame: Baseline, 1 week

    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.

  2. Clinical Wound Assessment

    Time frame: Pre-intervention, up to 3 weeks

    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.

  3. Follow up Clinical Wound Assessment

    Time frame: Follow Up, up to 4 weeks

    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.

  4. Numeric Rating Scale (1-10)

    Time frame: Post-intervention, up to 3 weeks

    Pain scale in relation to treatment. Higher scores indicate more pain.

  5. Wong Baker FACES (1-10)

    Time frame: Post-intervention, up to 3 weeks

    Visual Pain scale in relation to treatment. Higher scores indicate more pain.

  6. Investigator Questionnaire

    Time frame: 4 weeks

    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.

  7. Patient Questionnaire

    Time frame: 4 weeks

    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".

  8. Mean time of visit

    Time frame: For every visit, up to 4 weeks

    Total time for the visit will be measured in minutes.

  9. Mean time of Treatment Procedure

    Time frame: Post-intervention, up to 3 weeks

    For every treatment visit, time used for the treatment with the FlashHeal Device is measured.

    Time is measured in minutes.

  10. Baseline Mean Bacterial Load

    Time frame: 1 week

    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.

  11. Pre-intervention Mean Bacterial Load

    Time frame: Pre-intervention, up to 3 weeks

    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.

  12. Post-intervention Mean Bacterial Load

    Time frame: Post-intervention, up to 3 weeks

    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.

  13. Mean Bacterial Load at Follow Up

    Time frame: Follow up, up to 4 weeks

    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.

  14. Baseline Wound Fluid

    Time frame: Baseline, 1 Week

    Swab for wound fluid performed once every week using the Essen Rotary Technique, testing for 6-10 cytokines assessing the inflammatory microenvironment.

  15. Change from Baseline Wound Fluid Composition Week 1 to Week 2

    Time frame: 2 Weeks

    Swab for wound fluid performed once every week using the Essen Rotary Technique, testing for 6-10 cytokines assessing the inflammatory microenvironment.

  16. Change from Baseline Wound Fluid Composition Week 1 to Week 3

    Time frame: 3 Weeks

    Swab for wound fluid performed once every week using the Essen Rotary Technique, testing for 6-10 cytokines assessing the inflammatory microenvironment.

  17. Change from Baseline Wound Fluid Composition Week 1 to Week 4

    Time frame: 4 weeks

    Swab for wound fluid performed once every week using the Essen Rotary Technique, testing for 6-10 cytokines assessing the inflammatory microenvironment.

  18. Baseline Wound Size Week 1

    Time frame: Baseline, week 1

    Clinical Photography is performed once every week. Hereafter the wound is analysed with the ImageJ software to calculate wound size in cm2.

  19. Change from Baseline Wound Size Week 1 to Week 2

    Time frame: 2 Weeks

    Clinical Photography is performed once every week. Hereafter the wound is analysed with the ImageJ software to calculate wound size in cm2.

  20. Change from Baseline Wound Size Week 1 to Week 3

    Time frame: 3 Weeks

    Clinical Photography is performed once every week. Hereafter the wound is analysed with the ImageJ software to calculate wound size in cm2.

  21. Change from Baseline Wound Size Week 1 to Week 4

    Time frame: Follow Up, 4 weeks

    Clinical Photography is performed once every week. Hereafter the wound is analysed with the ImageJ software to calculate wound size in cm2.

  22. Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)

    Time frame: Post-intervention, 2 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). The CTCAE is adjusted to the skin.

  23. Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)

    Time frame: 30 minutes Post-intervention, 2 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). The CTCAE is adjusted to the skin.

  24. Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)

    Time frame: 24 hours Post-intervention, 2 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). The CTCAE is adjusted to the skin.

  25. Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)

    Time frame: 48 hours Post-intervention, 2 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). The CTCAE is adjusted to the skin.

  26. Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)

    Time frame: 120 hours Post-intervention, 2 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).

    The CTCAE is adjusted to the skin.

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

    Time frame: Follow Up, 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).

    The CTCAE is adjusted to the skin.

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Hvidovre University Hospital
  • Rigshospitalet, Denmark

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 22, 2023
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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