Light Treatment; Complications, Photobiology, Phototherapy Complication, Wound Heal, Wound Infection
Conditions
Keywords
Violet Blue Light, Blue Light, Safety
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
Interventions
DEVICEViolet-Blue Light Treatment / FlashHeal 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.
Sponsors
Hvidovre University Hospital
Rigshospitalet, Denmark
Bispebjerg Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE) | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Wound Assessment | 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. |
| Follow up Clinical Wound Assessment | 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. |
| Numeric Rating Scale (1-10) | Post-intervention, up to 3 weeks | Pain scale in relation to treatment. Higher scores indicate more pain. |
| Wong Baker FACES (1-10) | Post-intervention, up to 3 weeks | Visual Pain scale in relation to treatment. Higher scores indicate more pain. |
| Investigator Questionnaire | 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. |
| Patient Questionnaire | 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. |
| Mean time of visit | For every visit, up to 4 weeks | Total time for the visit will be measured in minutes. |
| Mean time of Treatment Procedure | 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. |
| Baseline Mean Bacterial Load | 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. |
| Pre-intervention Mean Bacterial Load | 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. |
| Baseline Clinical Wound Assessment | 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. |
| Mean Bacterial Load at Follow Up | 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. |
| Baseline Wound Fluid | 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. |
| Change from Baseline Wound Fluid Composition Week 1 to Week 2 | 2 Weeks | Swab for wound fluid performed once every week using the Essen Rotary Technique, testing for 6-10 cytokines assessing the inflammatory microenvironment. |
| Change from Baseline Wound Fluid Composition Week 1 to Week 3 | 3 Weeks | Swab for wound fluid performed once every week using the Essen Rotary Technique, testing for 6-10 cytokines assessing the inflammatory microenvironment. |
| Change from Baseline Wound Fluid Composition Week 1 to Week 4 | 4 weeks | Swab for wound fluid performed once every week using the Essen Rotary Technique, testing for 6-10 cytokines assessing the inflammatory microenvironment. |
| Baseline Wound Size Week 1 | 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. |
| Change from Baseline Wound Size Week 1 to Week 2 | 2 Weeks | Clinical Photography is performed once every week. Hereafter the wound is analysed with the ImageJ software to calculate wound size in cm2. |
| Change from Baseline Wound Size Week 1 to Week 3 | 3 Weeks | Clinical Photography is performed once every week. Hereafter the wound is analysed with the ImageJ software to calculate wound size in cm2. |
| Change from Baseline Wound Size Week 1 to Week 4 | 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. |
| Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE) | 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. |
| Post-intervention Mean Bacterial Load | 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. |
Countries
Denmark
Outcome results
None listed