Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers
Diabetic Foot, Diabetic Foot Ulcer, Diabetes
About this trial
This is an interventional treatment trial for Diabetic Foot focused on measuring Phototherapy, Blue Light Phototherapy, Light Therapy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Other
Experimental
Control
Phototherapy
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.
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.