Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers

Status: Withdrawn
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• English Speaking

• Capacity to Consent

• Diabetic Foot Ulcers

• Have an infected wound present on the foot greater than 1 (one) cm2 and less than 8 cm2

• Ability to utilize appropriate offloading devices as recommended by a clinician

Locations
United States
Massachusetts
Boston Medical Center
Boston
Time Frame
Start Date: June 2021
Completion Date: April 2022
Treatments
Other: Control
Subjects enrolled in the subject group will receive standard care treatment for infected diabetic wounds, including debridement surgery and wound dressings. However, in order to maintain consistency with the phototherapy arm, subjects within the control group will visit the clinic twice a week, with the first visit being for the debridement surgery, and the second visit being for clinical wound dressing redressing.
Experimental: Phototherapy
For this intervention therapy, subjects enrolled in the experimental group will still receive standard care treatment for infected diabetic wounds. However, experiment group subjects will receive phototherapy treatments alongside standard care. A mobile pulsed laser device will be utilized to apply nanosecond pulsed 410 nm light onto both the cellulitis afflicted regions and open wound portions of a patient's infected diabetic ulcer wound twice a week over the course of the 3 month study. The device will be designed and produced by the Ji Xin Cheng Lab located at the Boston University Charles River Campus. Phototherapy sessions will occur twice a week, with the first session occurring after debridement surgery, and the second session occurring later in the week during clinical wound dressing redressing.
Sponsors
Leads: Boston Medical Center
Collaborators: Ji-Xin Cheng Laboratory

This content was sourced from clinicaltrials.gov

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