Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers
- Conditions
- Diabetes MellitusInfected WoundDiabetesInfected Ulcer of SkinDiabetic Foot UlcerDiabetic Foot
- Interventions
- Device: PhototherapyProcedure: Debridement Surgery and Wound Dressing
- Registration Number
- NCT04285710
- Lead Sponsor
- Boston Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- Pregnant or breastfeeding/nursing
- Ankle-brachial pressure index below 0.45 or over 1.4
- Hemoglobin A1c levels above 12.0
- Stage 4 renal disease/dialysis
- Taking immunosuppressant medications
- Undergoing radiation therapy
- Diagnosed Uncontrolled/Resistant hypertension (HTN) - High blood pressure that does not respond well to medical treatment, blood pressure remains above average (usually 130/80 mmHg) despite medication usage.
- Diagnosed Uncontrolled malabsorption disorder - Small intestine unable to absorb nutrients effectively, usage of nutrient supplements ineffective
- Active sepsis
- Uncontrolled coagulopathy - Blood unable to properly coagulate and form clots, low platelet or clotting factor levels, unresponsive to medications
- Untreated bone/soft tissue infection - Not yet initially treated to reduce risk of sepsis
- Gangrene of wound under care
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phototherapy 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. Control Debridement Surgery and Wound Dressing 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. Phototherapy Debridement Surgery and Wound Dressing 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.
- Primary Outcome Measures
Name Time Method Bacterial Quantification Over Time 12 weeks 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.
- Secondary Outcome Measures
Name Time Method Wound Size Reduction Over Time 12 weeks 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.
Subject Phototherapy Treatment Satisfaction: questionnaire 12 weeks 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.
Trial Locations
- Locations (1)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States