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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
22
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.
Danish Wound Healing Center, Bispebjerg Hospital
Copenhagen, Northwest, Denmark
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.
Time frame: 4 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: Follow Up, up to 4 weeks
Numeric Rating Scale (1-10)
Pain scale in relation to treatment. Higher scores indicate more pain.
Time frame: Post-intervention, up to 3 weeks
Wong Baker FACES (1-10)
Visual Pain scale in relation to treatment. Higher scores indicate more pain.
Time frame: 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.
Time frame: 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".
Time frame: 4 weeks
Mean time of visit
Total time for the visit will be measured in minutes.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Follow Up, 4 weeks
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