Diabetic FootNCT04285710
Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers
A study testing Phototherapy and Debridement Surgery and Wound Dressing in people with Diabetic Foot and Diabetic Foot Ulcer, run by Boston Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Diabetic Foot Ulcer, Diabetes
- What is being tested?
- Phototherapy and Debridement Surgery and Wound Dressing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2021to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Diabetes, Diabetes Mellitus, Infected Wound, Infected Ulcer of Skin
- Being tested
- Phototherapy, Debridement Surgery and Wound Dressing
- Keywords
- Phototherapy, Blue Light Phototherapy, Light Therapy
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototherapyDevice
Also called OPOTEK Opolette HE 355 LD Tunable Laser
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.
Debridement Surgery and Wound DressingProcedure or surgery
Also called Debridement
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | 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. Receives: Procedure: Debridement Surgery and Wound Dressing |
| Phototherapy | Experimental | 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. Receives: Device: Phototherapy; Procedure: Debridement Surgery and Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study startJun 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: This study was never started since the IRB application was not submitted and the PI left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ji-Xin Cheng Laboratory
- Responsible party
- Sponsor
- Investigators
- David Negron, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285710
- Sponsor's protocol ID
- H-38602
- Status last verified
- May 2021
- First submitted
- 24 Feb 2020
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Phototherapy Treatment of Infected Diabetic Ulcers
- ClinicalTrials.gov ID
- NCT04285710
- Acronym / sponsor ID
- H-38602
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Diabetes, Diabetes Mellitus, Infected Wound, Infected Ulcer of Skin
- Keywords
- Phototherapy, Blue Light Phototherapy, Light Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was never started since the IRB application was not submitted and the PI left the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Ji-Xin Cheng Laboratory
- Study start
- Jun 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Procedure: Debridement Surgery and Wound DressingSubjects 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 | Experimental | Device: Phototherapy, Procedure: Debridement Surgery and Wound DressingFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhototherapyAlso: OPOTEK Opolette HE 355 LD Tunable LaserThe 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. | Device | Phototherapy |
| Debridement Surgery and Wound DressingAlso: DebridementAll 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. | Procedure or surgery | Control, Phototherapy |
Primary outcome
Bacterial Quantification Over Time
Time frame: 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.
2 secondary outcomes
Wound Size Reduction Over Time
Time frame: 12 weeks
Subject Phototherapy Treatment Satisfaction: questionnaire
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Negron, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phototherapy and Debridement Surgery and Wound Dressing in people with Diabetic Foot and Diabetic Foot Ulcer, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial Quantification Over Time (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.