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Violet-Blue Light Inactivation of Bacteria in Chronic Wounds

NCT05739058 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-05-03

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Hvidovre University Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Frederik Plum, MD · Danish Wound Healing Center, Bispebjerg Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-22
Primary Completion
2024-05-01
Completion
2024-05-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05739058 on ClinicalTrials.gov