Methylene Blue-Photodynamic Therapy for Burns

NA
Overseen ByNicole A. Wilson, PhD, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Oklahoma
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for burn wounds at risk of infection. Methylene Blue-Photodynamic Therapy combines methylene blue, a dye, with blue light to kill bacteria in wounds. Participants will receive either this new treatment or just blue light during regular dressing changes to assess its effectiveness in reducing infections and improving healing. Individuals with partial- or full-thickness burns requiring dressing changes for at least a week may qualify. The trial will also evaluate the treatment's safety and comfort. As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to benefit from this innovative approach.

Will I have to stop taking my current medications?

If you are currently taking SSRIs, SNRIs, monoamine oxidase inhibitors, or other serotonergic medications, you will need to stop taking them to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that methylene blue-photodynamic therapy (MB-PDT) is generally easy for patients to handle. In past studies, patients who received this treatment experienced less wound fluid without any harmful local reactions, suggesting the therapy is safe for treating burns. Other research supports its safety, indicating that MB-PDT can reduce smell, fluid leakage, and wound size. Most patients tolerated the treatment well.

Although this trial is in its early stages, previous evidence suggests that methylene blue-photodynamic therapy could be a safe option for managing burn wounds.12345

Why do researchers think this study treatment might be promising for burns?

Unlike the standard burn care treatments, which typically involve topical antibiotics and regular dressing changes, Methylene Blue-Photodynamic Therapy stands out with its unique approach. This therapy uses methylene blue, a dye that, when exposed to blue light, generates reactive oxygen species to target and kill harmful bacteria in burn wounds. This mechanism could potentially speed up healing and reduce infection risk. Researchers are excited about this treatment because it combines a straightforward application with a novel light-activated action, offering a promising alternative to conventional methods.

What evidence suggests that methylene blue-photodynamic therapy might be an effective treatment for burn wound bacterial contamination?

Research has shown that methylene blue-photodynamic therapy (MB-PDT), which participants in this trial may receive, can effectively reduce bacterial infections in burn wounds. Studies indicate that it speeds up healing by lowering inflammation markers like TNF-α and IL-6 and boosting growth factors that aid recovery. In trials, patients experienced a significant reduction in wound size and fewer infection-related symptoms, such as bad odor. MB-PDT has also successfully treated infections from difficult-to-treat bacteria. Overall, MB-PDT appears promising as a non-antibiotic treatment for burn wound infections.13456

Who Is on the Research Team?

NA

Nicole A. Wilson, PhD, MD

Principal Investigator

University of Oklahoma Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults (18+) with partial- or full-thickness burns that include a partial-thickness area and will need dressing changes for at least a week. People can't join if they're pregnant, breastfeeding, unable to consent, taking certain antidepressants, or can't tolerate wound exposure.

Inclusion Criteria

I am 18 years old or older.
Ability to provide informed consent
I have a burn that includes at least some partial-thickness injury.
See 1 more

Exclusion Criteria

Inability to provide informed consent
I am currently taking antidepressant or serotonergic medications.
I cannot tolerate having my wound exposed for the procedure.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive methylene blue-photodynamic therapy or light therapy alone during two consecutive dressing changes

2 days
2 visits (in-person)

Follow-up

Participants are monitored for safety, tolerability, and wound healing after treatment

7 days
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Methylene Blue-Photodynamic Therapy

Trial Overview

The study compares two treatments during burn dressing changes: one group gets methylene blue applied to the wound followed by blue light therapy (photodynamic therapy), while the other group receives only blue light. The goal is to see if adding methylene blue helps reduce bacteria in burn wounds.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Methylene Blue Photodynamic TherapyExperimental Treatment2 Interventions
Group II: Light Therapy AloneActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials
484
Recruited
95,900+

University of Rochester

Collaborator

Trials
883
Recruited
555,000+

Citations

Photodynamic therapy mediated by methylene blue-loaded ...

MB-PEG based hydrogel improves and accelerates wound closure in the context of laser compared to either single treatment.

Topical Methylene Blue-Photodynamic Therapy (MB-PDT) ...

The primary objective of this study is to determine whether methylene blue photodynamic therapy reduces bacterial burden in burn wounds compared with light ...

Photodynamic therapy for treatment of burns

The results of the meta-analysis showed that PDT effectively reduces TNF-α and IL-6 levels in wounds, and increases bFGF and VEGF levels, PDT can also reduce ...

Treatment of chronic wounds with methylene blue ...

The results were satisfactory, with significant wound size reduction, and a decrease in aspects indicative of infection including odor, presence ...

Control of Burn Wound Infection by Methylene Blue ...

Results. Even in the aPDT group, rapid bacterial regrowth was observed on the wound surface after each day's treatment, but the geometric mean ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33655570/

Control of Burn Wound Infection by Methylene Blue ...

In this study, we examined the usefulness of methylene blue (MB)-mediated antimicrobial photodynamic therapy (aPDT) with illumination by a light ...