Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

June 30, 2021

Primary Completion Date

April 30, 2022

Study Completion Date

April 30, 2022

Conditions
Diabetic FootDiabetic Foot UlcerDiabetesDiabetes MellitusInfected WoundInfected Ulcer of Skin
Interventions
DEVICE

Phototherapy

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.

PROCEDURE

Debridement Surgery and Wound Dressing

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.

Trial Locations (1)

02118

Boston Medical Center, Boston

Sponsors
All Listed Sponsors
collaborator

Ji-Xin Cheng Laboratory

UNKNOWN

lead

Boston Medical Center

OTHER