Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers

Diabetes Clinical Trial

Official title:

Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04285710
• Other study ID #: H-38602
• Status: Withdrawn
• Phase: N/A
• Start date: June 2021
• Est. completion date: April 2022

Study information

• Verified date: May 2021
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Infected Ulcer of Skin
• Infected Wound
• Ulcer

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Ji-Xin Cheng Laboratory

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial Quantification Over Time	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.	12 weeks
Secondary	Wound Size Reduction Over Time	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.	12 weeks
Secondary	Subject Phototherapy Treatment Satisfaction: questionnaire	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.	12 weeks