Violet-Blue Light Inactivation of Bacteria in Chronic Wounds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-22

Study Completion Date

2024-05-01

Brief Summary

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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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Detailed Description

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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

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Phototherapy Complication Photobiology Light Treatment; Complications Wound Infection Wound Heal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Low Exposure to Violet-Blue Light

ID 1-7 are assigned to the low dosage group

Group Type EXPERIMENTAL

Violet-Blue Light Treatment / FlashHeal Device

Intervention Type 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.

Medium Exposure to Violet-Blue Light

ID 8-15 are assigned to the medium dosage group

Group Type EXPERIMENTAL

Violet-Blue Light Treatment / FlashHeal Device

Intervention Type 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

ID 16-22 are assigned to the high dosage group

Group Type EXPERIMENTAL

Violet-Blue Light Treatment / FlashHeal Device

Intervention Type 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.

Interventions

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Violet-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.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No