The key purpose of this study is to determine and understand the safety and effectiveness of blue light phototherapy in the treatment and healing of infected diabetic wounds, as well as determining if this treatment is capable of reducing the bacterial population number within infected wounds. The investigators' lab recently discovered that a specific survival protein called catalase can be destroyed through blue light exposure. Given that a majority of bacteria species contains catalase, it is hypothesized that the destruction of this protein can improve the effectiveness of antimicrobial wound dressings commonly used to treat infected diabetic wounds, therefore further reducing the amount of bacteria within the wound and increasing the rate of healing. By reducing the overall bacterial population within these diabetic infected wounds, the ability for these diabetic wounds to heal will be enhanced, allowing for greater reductions in wound size over the course of the treatment. In this study, 40 subjects will be enrolled and randomly assigning subjects to either a control group or a phototherapy receiving experimental group. While control subjects will receive standard weekly debridement treatment procedures for infected diabetic ulcers, experimental subjects will receive standard weekly debridement treatment alongside 2 sessions of phototherapy every week over the course of 12 weeks. Bacterial swab samples will be taken alongside the excised debrided infect tissue for the purpose of bacterial population analysis. For each patient, the changes in total bacterial population, wound size, and subject satisfaction will be recorded and analyzed to determine the effectiveness of pulsed light phototherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
The key intervention aspect of this study is the application of 15 J/cm2 of 410 nm pulsed light directly onto the infected diabetic wounds of subjects every week over the course of 3 months, allowing for the cumulative exposure of around 180 J/cm2 for the entire study. This 15 J/cm2 weekly dosage of blue light will split up into two sessions every week, with each session applying 7.5 J/cm2 of light treatment. Phototherapy will be applied twice per week, with one phototherapy session occurring directly following the debridement surgery during the first visit of the week and the other session occurring after the study clinician removes the subjects wound dressings at the second visit.
All patients enrolled in the study will undergo standard care and treatment for infected diabetic wounds, which includes the weekly surgical removal of infected necrotic tissue from the diabetic wounds. In addition to debridement, both groups will utilize an antimicrobial wound dressing to cover and treat the infected diabetic wound. The subject's wounds will be dressed with Aquacel Ag Advantage Wound Dressings to protect and treat their diabetic wounds. These dressings will be changed twice a week by clinicians.
Boston Medical Center
Boston, Massachusetts, United States
Bacterial Quantification Over Time
Bacterial swabs will be collected from each subject's wound before and after weekly debridement. These weekly bacterial swabs, in addition to the homogenized debrided tissue, will be used to assess a patient's overall bacterial burden and bacterial population. Overall bacterial counts and population within each sample will be determined through the use of colony-forming unit (CFU) counting on agar plates or bacterial sequencing.
Time frame: 12 weeks
Wound Size Reduction Over Time
Participants will have their diabetic wounds imaged and measured on a week-to-week basis, determining the changes in wound area and cellulitis afflicted area.
Time frame: 12 weeks
Subject Phototherapy Treatment Satisfaction: questionnaire
An investigator developed questionnaires will be completed each week by the participants that asks questions about their overall satisfaction with the treatment regimen and whether changes will need to be made to the phototherapy treatment procedure to ensure a better patient experience.
Time frame: 12 weeks
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