Clinical trial NCT04285710: Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers
Official title: Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetic Foot
Diabetic Foot Ulcer
Diabetes
Diabetes Mellitus
Infected Wound
Infected Ulcer of Skin
Keywords: Phototherapy
Blue Light Phototherapy
Light Therapy
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Ji-Xin Cheng Laboratory
First posted: 2020-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Bacterial Quantification Over Time
timeFrame: 12 weeks
Secondary outcomes:
measure: Wound Size Reduction Over Time
timeFrame: 12 weeks
measure: Subject Phototherapy Treatment Satisfaction: questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: David Negron, MD
role: PRINCIPAL_INVESTIGATOR
References: