An Early Phase 1 interventional study of Methylene Blue and Blue Light Illumination in Burns and Wound Infection, sponsored by University of Oklahoma. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by University of Oklahoma · Early Phase 1, Interventional, and Treatment
Among 336 studies in Burns with a site in United States — 40 open to participants now, 52 under way, 5 of them phase 3. Burns · United States.
Among the 336 studies in Burns with a site in United States, this one is the 69th largest by planned enrollment of the 272 interventional ones that give a count, is one of 15 that started in 2026, is one of 25 in phase 1, reaches primary completion later than 39 of the 51 other live ones, and was the 331st registered.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
Browse Burns studies →40 of the 336 studies in Burns with a site in United States are open now. Recruiting first, the newest first:
Jason Sperry · Sites in United States
Ages 18–75
University of Texas Southwestern Medical Center · Sites in United States
Ages 18–65 · Healthy volunteers
Johns Hopkins University · Sites in United States
Ages 18+
University of Tennessee · Sites in United States
Ages 18–80
The Metis Foundation · Sites in United States
Ages 18–85
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 84 Burns studies recruiting now, 38 (45%) set no upper age limit and 37 (44%) stop at 75 or younger; 17 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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336 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 35 · Phase 2 56 · Phase 3 30 · Phase 4 25
First in 1992; this study’s year is marked. 15 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is above the median of 40 across 663 interventional studies indexed under Burns.
Median enrollment 26 across the 272 interventional studies, 59 across the 61 observational. Of the 225 that completed or were terminated, 74 (33%) have results posted.
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82 of 336 have an industry lead sponsor. The 10 most frequent:
University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
University of Oklahoma has 1 study filed under Burns — fewer than ten, so there is no comparison to draw.
10 of the studies in Burns with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05223998The Metis FoundationManual Implantation of Full-Thickness Skin Microcolumns | 2026-12 |
| NCT07317271Johns Hopkins UniversityVR-PMR for Post-Burn Symptoms | 2026-12 |
| NCT05462860The Metis FoundationSuprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds | 2026-12-09 |
| NCT01297400Skingenix, Inc.Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns | 2026-12-31 |
| NCT07221903University of WashingtonThe Lateral, Anterior, Medial (LAM) Femoral Cutaneous Block: A Case Series Harborview Medical Center, Seattle, WA | 2026-12-31 |
Among the 336 studies in Burns with a site in United States, from their registry updates:
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Burn wound infections remain a major source of morbidity in patients with thermal injuries and contribute to delayed healing, graft loss, and prolonged hospitalization. The emergence of antimicrobial-resistant organisms further complicates management and highlights the need for non-antibiotic antimicrobial strategies. Photodynamic therapy (PDT) is an antimicrobial approach that combines a photosensitizing agent with visible light to generate reactive oxygen species capable of killing bacteria.
This randomized clinical trial will evaluate the safety and preliminary efficacy of methylene blue-mediated photodynamic therapy for the treatment of burn wound bacterial contamination. Participants receiving standard burn care will be randomized to receive either methylene blue-photodynamic therapy with blue light illumination or light therapy alone during routine dressing changes. Treatments will occur during two consecutive dressing changes. The primary objective is to determine whether methylene blue photodynamic therapy reduces bacterial burden in burn wounds compared with light therapy alone. Secondary outcomes include safety, tolerability, and effects on wound healing.
Burn wound infections remain a major complication following thermal injury and contribute to delayed wound healing, graft failure, prolonged hospitalization, and increased healthcare utilization. Management of burn wound bacterial contamination relies heavily on topical and systemic antibiotics. However, the increasing prevalence of antimicrobial-resistant organisms has created a need for alternative antimicrobial strategies that do not rely on conventional antibiotics. Photodynamic therapy (PDT) is a non-antibiotic antimicrobial approach that combines a photosensitizing compound with visible light to generate reactive oxygen species that rapidly kill bacteria through oxidative damage.
Methylene blue is a well-characterized photosensitizer with known antimicrobial activity when activated by visible light. When exposed to appropriate wavelengths of light, methylene blue produces singlet oxygen and other reactive oxygen species that disrupt bacterial cell membranes and intracellular components. Photodynamic therapy has demonstrated broad antimicrobial activity in laboratory and preclinical studies, including activity against antibiotic-resistant organisms. The use of PDT for treatment of contaminated wounds offers the potential to reduce bacterial burden while minimizing the risk of antimicrobial resistance.
This study is a randomized clinical trial designed to evaluate the safety and preliminary antimicrobial efficacy of methylene blue-mediated photodynamic therapy in burn wounds. Participants receiving standard burn care will be randomized to receive either methylene blue photodynamic therapy with blue light illumination or light therapy alone during routine dressing changes. Treatments will occur during two consecutive dressing changes. Methylene blue will be applied to the burn wound surface prior to illumination with a blue light source.
The primary objective of this study is to determine whether methylene blue photodynamic therapy reduces bacterial burden in burn wounds compared with light therapy alone. Secondary objectives include evaluation of treatment safety, tolerability, and effects on wound healing. Results from this study will inform the feasibility and design of future trials evaluating photodynamic therapy as a novel adjunctive treatment for burn wound infection.
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Exclusion
Pregnancy or lactation
o Pregnancy status will be determined by review of the medical record and, when clinically indicated per institutional policy, standard-of-care pregnancy testing. No additional pregnancy testing will be performed solely for research purposes.
Participants in this arm will receive methylene blue-mediated photodynamic therapy during routine burn dressing changes. Methylene blue will be applied to the burn wound surface followed by illumination with blue light using a clinical light source. Treatments will be administered during two consecutive dressing changes in addition to standard burn care.
Drug: Methylene Blue · Device: Blue Light Illumination
Participants in this arm will receive blue light illumination during routine burn dressing changes without application of methylene blue. Treatments will be administered during two consecutive dressing changes in addition to standard burn care.
Device: Blue Light Illumination
Methylene blue will be applied topically to the burn wound surface prior to illumination. When activated by visible blue light, methylene blue acts as a photosensitizer that generates reactive oxygen species capable of killing bacteria. Methylene blue-mediated photodynamic therapy will be administered during two consecutive burn dressing changes.
Also known as: Methylthioninium Chloride
Burn wounds will be illuminated using a clinical blue light source during routine dressing changes. In the experimental arm, illumination will occur after topical application of methylene blue to activate photodynamic therapy. In the control arm, illumination will occur without methylene blue application.
Also known as: Bili-lamp; Blue Light Phototherapy
Wound Healing Trajectory Measured by Digital Planimetry
Burn wound healing will be quantified using standardized digital photography and planimetric image analysis to measure wound surface area over time. Images will be obtained using a calibrated imaging system with a measurement scale included in each image. Wound area measurements will be analyzed longitudinally to assess changes in wound size over the study period.
Time frame: Baseline, post-intervention Day 1, post-intervention Day 2, and approximately 7 days after intervention
Change in Quantitative Bacterial Burden
Quantitative bacterial burden will be measured using standardized surface wound swab cultures obtained during routine dressing changes. Bacterial load will be quantified using colony-forming unit (CFU) counts and analyzed as log₁₀ change from baseline to post-intervention measurements.
Time frame: Baseline, post-intervention Day 1, and post-intervention Day 2
Intervention Feasibility
Feasibility will be assessed by the proportion of participants who successfully complete both intervention sessions during routine dressing changes without protocol deviation or early termination.
Time frame: Intervention Day 1 and Intervention Day 2
Participant-Reported Pain During Intervention
Pain will be assessed using a participant-reported 0-10 numeric rating scale obtained immediately before and immediately after each intervention session to evaluate treatment tolerability.
Time frame: Immediately before and immediately after each intervention session (two sessions)
Treatment-Related Adverse Events
Adverse events potentially related to methylene blue application or visible light exposure will be recorded and graded according to CTCAE v5.0 criteria, including local wound reactions, unexpected pain escalation, or signs of systemic toxicity.
Time frame: From first intervention through 7 days post-intervention
Plan to share: No — Individual participant data will not be shared. De-identified aggregate study results may be reported in scientific publications and presentations.
Start is estimated for Jun 2026; primary completion for May 2028, 23 months later.
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Studies of the drug tested here: Methylene Blue