Clinical Evidence

Backed by 25+ years of peer-reviewed research and Nobel Prize-winning science

25 Years of Clinical Validation

1998
Nobel Prize

Nitric Oxide Discovery

Nobel Prize in Medicine awarded for discovering that nitric oxide acts as the body's natural vasodilator, expanding blood vessels to increase circulation.

1999
Clinical Study

First Infrared Wound closure Research

Horwitz, Burke, and Carnegie publish groundbreaking study showing 890nm monochromatic infrared energy accelerates closure of diabetic and venous ulcers.

2004
⭐ Breakthrough

80% Prevention Discovery

Powell, Carnegie, and Burke demonstrate that infrared therapy prevents 80% of diabetic foot wounds by restoring protective sensation. Only 1.5% vs expected 7.3% developed wounds.

2017
Systematic Review

Drug-Free Approach Validated

International systematic review confirms red and near-infrared photobiomodulation as a "promising drug-free approach" for wound closure, with 800-830nm as most-studied range.

2024
Clinical Protocols

Optimized Treatment Guidelines

Dr. Burke provides refined clinical protocols based on decades of experience: optimal duration, frequency, and spacing for maximum closure outcomes.

Published Clinical Research

Research organized by clinical outcomes, evidence synthesis and biological mechanisms

Understanding the Research on Light Therapy

Explore the research on red and near-infrared light therapy for wound care. To help patients and doctors navigate the findings, we’ve grouped the studies into three categories: results from patient studies, reviews that bring together multiple studies, and research into how light may affect the body.

Priority clinical studies by wavelength

Red and Near-Infrared Photobiomodulation for Diabetic Wounds

A growing body of clinical research has investigated red and near-infrared photobiomodulation (PBM), also known as low-level light or laser therapy (LLLT), for chronic diabetic wounds, particularly diabetic foot ulcers. The studies below examine light therapy alongside conventional wound care or explore physiological responses to treatment.

Clinical study comparison — direct human evidence
StudyLight usedPatients / woundsKey finding
Borges et al., 2024 — Lasers in Medical Science
PubMed: red and infrared LED trial ↗
Red and infrared LED treatment groups Patients with diabetes and Grade I–II foot ulcers; home treatment for 12 weeks Both red and infrared groups showed a tendency toward faster wound healing; infrared LED produced the greatest reduction in ulcer area among the light groups.
Cardoso et al., 2024 — 904 nm PBM randomized controlled trial
PubMed: 904 nm PBM trial ↗
904 nm infrared 80 patients with non-infected diabetic foot ulcers The study reported significant reductions in ulcer size. In the 10 J/cm² treatment group, 60% of ulcers healed completely during the study period.
Kaviani et al., 2011 — Photomedicine and Laser Surgery
PubMed: chronic diabetic foot wound trial ↗
685 nm red laser 23 patients with diabetic foot wounds lasting at least 3 months After 20 weeks, complete healing was reported in 8 of 13 patients in the laser group versus 3 of 10 receiving placebo; mean healing time was 11 versus 14 weeks.
Chronic diabetic foot ulcer randomized controlled trial
PMC: low-level laser therapy trial ↗
Low-level laser therapy 68 patients with Type 2 diabetes and Wagner Grade I ulcers Ulcer-area reduction was substantially greater with LLLT plus conventional care than with conventional care alone.
2024 randomized controlled trial — visible and infrared PBM
PMC: visible and infrared PBM trial ↗
Visible and infrared laser 60 patients with diabetic foot ulcers Mean ulcer area decreased by approximately 63% in the laser group, while the control group's mean ulcer area did not change significantly.

How to interpret this research: These studies used different devices, wavelengths, doses and treatment schedules. Their findings do not establish that Wound Blaster itself heals diabetic wounds or identify a treatment protocol for this device. PBM was investigated as an adjunct, not a replacement for clinician-directed wound care, including infection management, off-loading, dressings and vascular assessment. Study findings should be considered alongside their design limitations and sample sizes.

Tier 1 — Direct Clinical Evidence

These priority studies investigate clinical outcomes in people with diabetic wounds. They provide background for investigating red and near-infrared PBM, rather than proof of the effectiveness of Wound Blaster itself. Use the wavelength groups above to navigate the individual trials. Torkaman’s wound-area results belong here; its biomarker findings are considered separately in Tier 3.

Research settings, not treatment instructions: Wavelengths, energy densities and schedules below describe research protocols. They are not recommendations for self-treatment or a validated Wound Blaster protocol. Diabetic wounds require clinician-directed care. Devices, study populations and outcomes differ, and preliminary or mechanistic findings should not be treated as established clinical benefits.

2024Randomized Trial

904 nm — Cardoso et al., 2024: PBM for Diabetic Foot Ulcers

A randomized, double-blind, placebo-controlled trial involved 80 people with non-infected diabetic foot ulcers. Researchers compared 904-nm photobiomodulation at 4, 8 and 10 J/cm² with a placebo/control, alongside conventional wound care.

Reported finding

The study reported reduced ulcer size with PBM and 60% complete healing in the 10 J/cm² group. This result applies to that study group and protocol, not to all PBM devices or patients.

Research relevance: This is direct human clinical evidence involving infrared PBM and diabetic foot ulcers, rather than an inference from cell or animal studies. It is an important starting point for reviewing the modality, while device-specific evidence is still needed.

2018LED Clinical Study

850 nm with Red Light — LED Phototherapy for Chronic Diabetic Wounds, 2018

Phototherapy with LED Shows Promising Results in Healing Chronic Wounds in Diabetes Mellitus Patients examined 60 patients using a light system incorporating 625, 660 and 850 nm.

  • Energy density: 2.4 J/cm².
  • Schedule: three treatments per week for eight weeks.
  • Comparator: simulated-light control.
Reported finding

The researchers reported significantly faster wound-bed healing with LED treatment than with simulated light.

Research relevance: This study includes an 850-nm near-infrared LED alongside red wavelengths, making it useful when reviewing LED-based approaches. A combined-wavelength study does not isolate the effect of 850 nm or establish equivalence to Wound Blaster.

2021Home-Use Pilot

808 nm — At-Home PBM for Severe Diabetic Foot Ulcers

A randomized, double-blind, sham-controlled pilot study evaluated at-home photobiomodulation laser therapy in people with severe diabetic foot ulcers and significant coexisting conditions. Participants continued standard wound care. The study used 808-nm pulsed near-infrared light at 8.8 J/cm².

Reported endpoint findings
  • PBM group: median wound area decreased from 20.3 cm² to 0.2 cm².
  • Sham group: median wound area decreased from 7.9 cm² to 4.6 cm².
  • More than 90% wound closure occurred in 7 of 10 PBM patients and 1 of 10 sham patients.
  • No adverse device effects were observed in this small study.

Research relevance and limitations: This offers a precedent for investigating home-based PBM, rather than only clinic-administered treatment. The authors described the results as preliminary and recommended a larger trial. The small sample and differing starting wound areas matter; absence of observed adverse effects does not establish general safety.

2024Mechanistic Trial

904 nm — Torkaman et al., 2024: Clinical Outcomes and Vascular Signaling

A double-blind randomized trial involved 30 patients with Grade II diabetic foot ulcers. Both groups received standard wound care. The reported PBM protocol used 904 nm at 2 J/cm², three days per week over four weeks, with 11 sessions.

The investigators examined HIF-1α, VEGF, VEGFR-2, nitric oxide and wound surface-area reduction—measures relevant to oxygen-response pathways, angiogenesis and wound healing.

Reported finding

The PBM group had significantly greater wound-area reduction. The study also investigated biological pathways that may help explain treatment responses.

Research relevance: These findings can inform a scientific rationale for studying PBM. Changes in biomarkers must not be turned into claims that Wound Blaster improves circulation, oxygenation or healing.

2024Randomized Trial

Red and Infrared LED — Borges et al., 2024

The trial studied red and infrared LED treatment groups in patients with Grade I–II diabetic foot ulcers, with home treatment over 12 weeks.

Reported finding

Both light groups showed a tendency toward faster wound healing. Infrared LED produced the greatest reduction in ulcer area among the light groups.

Research relevance: This is human clinical evidence involving home-based LED treatment. The findings relate to the studied devices and protocols, not a demonstrated benefit of Wound Blaster. Red and infrared treatment groups should not be confused with a single combined-wavelength treatment.

Tier 2 — Evidence Synthesis

Reviews place the individual studies in context. Consider their search methods, included study designs, sample sizes and limitations; systematic reviews and narrative reviews do not provide the same type of synthesis.

2024Systematic Review

2024 Systematic Review and Meta-Analysis — 28 Studies / 1,471 Patients

This review included 28 randomized studies involving 1,471 patients and examined red and infrared light as adjuncts to conventional diabetic foot ulcer care.

Reported pooled findings
  • Higher ulcer-healing rate: relative risk 1.93.
  • Shorter healing time: approximately 18.5 days on average.
  • Increased dorsalis pedis artery blood-flow velocity.
  • Reduced wound pain.
  • No statistically significant difference in adverse events between treatment and control groups.

Evidence limitations: The authors noted limitations in study quality and sample size and called for additional high-quality research. Pooled estimates are not predictions for an individual patient or proof of a specific device's performance. A non-significant adverse-event difference is not proof that risks are absent.

2023LED Systematic Review

LED Systematic Review — Tissue Repair in Chronic Diabetic Wounds

Baracho and colleagues' systematic review selected eight articles evaluating LED phototherapy in chronic wounds in people with diabetes, including randomized and observational clinical studies.

Review conclusions

The review described evidence suggesting benefits involving tissue repair, collagen production, fibroblasts, angiogenesis, reduced inflammation and smaller lesions.

Research relevance and limitations: LED-specific literature adds context beyond laser studies alone. Results were not uniform, treatment parameters varied, and some studies had small samples or other methodological limitations. The review supports further research rather than a universal treatment protocol.

2021Narrative Synthesis

2021 Review — Diabetic Foot and Lower-Leg Ulcer Healing

Sutton and colleagues' review examined 13 studies involving 417 participants. Wavelengths associated with favorable healing outcomes included red light at 630 and 660 nm and near-infrared light at 850 and 890 nm.

Commonly favorable radiant exposures were reported in the approximate range of 3–7 J/cm², but the protocols varied substantially.

How to interpret the range

These studies do not establish one universally correct wavelength, dose or treatment schedule. Their findings must be considered with the light source, delivery method, wound characteristics and conventional care used in each study.

2021Review

Red and Near-Infrared PBM in Diabetic Wound Healing

Photobiomodulation in diabetic wound healing: A review of red and near-infrared wavelength applications.

This reference complements the LED-specific and foot/lower-leg ulcer reviews in the evidence synthesis. Its scope concerns red and near-infrared applications; it is not a Wound Blaster clinical trial.

Review note: The full text was not available for verification here. Consult the original paper for its methods, findings and limitations before using it in a clinical or regulatory submission.

Tier 3 — Mechanistic Evidence

Keep biological pathways, tissue measurements and proposed mechanisms separate from clinical healing outcomes. These topics help frame research questions; listing them does not mean that every pathway has been demonstrated in humans or with Wound Blaster.

Nitric oxide
Document measured nitric oxide findings separately from claims about circulation or healing. The Torkaman trial includes nitric oxide among its investigated markers.
VEGF
Record VEGF and VEGFR-2 findings as vascular-signaling markers. A biomarker change is not itself evidence of wound closure.
Angiogenesis
Distinguish proposed blood-vessel formation pathways from directly measured vascular changes and clinical outcomes.
Mitochondrial activity
Document cellular-energy hypotheses with their source and experimental model; do not extrapolate cellular findings directly to patient benefit.
Fibroblast activity
Keep cell-level repair findings separate from wound-area reduction and complete healing in patients.
Collagen
Distinguish collagen-production or remodeling measurements from clinical healing endpoints.
Inflammation
Identify the specific inflammatory markers, tissue and study design rather than implying a general anti-inflammatory benefit.
Microcirculation
Record vascular or blood-flow measurements as physiological endpoints, not substitutes for clinical wound outcomes.
Oxygenation
Separate oxygen-response biomarkers and spectroscopy measurements from demonstrated tissue oxygen delivery or healing.

Evidence documentation: For each mechanism, record the source, human/animal/cell model, measured endpoint and limitations. The Torkaman trial informs the vascular-signaling discussion; the LED review provides context on repair-related mechanisms. Neither proves all of the mechanisms listed above or establishes a Wound Blaster clinical benefit.

Physiological Evidence

Near-Infrared Spectroscopy — Physiological Responses, Not Healing Outcomes

This study used near-infrared spectroscopy to examine responses to low-level light therapy in 45 patients with diabetic foot ulcers, plus healthy controls. Researchers monitored total hemoglobin concentration and vascular or nervous-system responses following treatment.

Measurement is different from treatment

Near-infrared spectroscopy measures tissue responses. It should not be confused with near-infrared PBM used as treatment, and physiological changes alone do not establish wound healing.

Research relevance: This work can inform the rationale for investigating light therapy and possible mechanisms, while remaining separate from clinical healing outcomes.

Additional Historical and Technical Background

Earlier clinical reports, reviews, industry commentary and modeling provide context beyond the priority studies above. Their evidence types and limitations should be assessed separately.

1999 Peer-Reviewed

Augmentation of Wound closure Using Monochromatic Infrared Energy

L.R. Horwitz, T.J. Burke, D. Carnegie

Advances in Wound Care, Jan-Feb 1999

Key Finding

890nm monochromatic infrared energy successfully treats diabetic ulcers, venous ulcers, and scleroderma-related wounds that failed conventional treatment. closure mechanism linked to local nitric oxide increases.

2017 Systematic Review

Red and Near-Infrared Photobiomodulation for Impaired Wound closure

Anju Yadav, Asheesh Gupta

Photodermatol Photoimmunol Photomed, Jan 2017

Key Finding

Systematic review confirms photobiomodulation as "promising drug-free approach" for wound closure. Near-infrared wavelengths (800-830nm) identified as most-studied and effective range.

2020s Expert Review

Light Therapy for Wound closure: An Emerging Solution

Lumitex Industry Analysis

Lumitex Clinical Review

Key Finding

Comprehensive review of light therapy mechanisms showing near-infrared (750-950nm) penetrates deepest, enhances mitochondrial energy, promotes collagen synthesis, and accelerates closure times.

2017 Technical Study

Wavelength and Beam Width Effects on Light Penetration

Caerwyn Ash, Michael Dubec, Kelvin Donne, Tim Bashford

Lasers in Medical Science, Sep 2017

Key Finding

Monte Carlo modeling confirms near-infrared wavelengths achieve maximum tissue penetration (5.4mm), validating 890nm as optimal for reaching deep tissue and blood vessels.

Dr. Thomas J. Burke

Thomas Joseph Burke, Ph.D.

Science and Medical Director, HealthLight PN LLC

  • Associate Professor of Medicine and Physiology, University of Colorado Medical School (retired 1997)
  • Postdoctoral Training: Duke Medical School
  • Education: Ph.D. University of Houston, M.S. Adelphi University, B.S. Niagara University
  • Co-Author of Original 1999 Infrared Wound closure Study with Horwitz & Carnegie
  • Published Expert in Photobiomodulation and Monochromatic Infrared Energy Since 1999
  • Author of 90+ Peer-Reviewed Publications on Renal Physiology and Photobiomodulation
  • Member: American Society of Nephrology, American Physiological Society, American Heart Association

Download Research Materials

Ready to Experience the Science?

Based on decades of research, Wound Blaster brings clinical-grade wound closure technology to your home. Simple, effective, proven.

Contact the Team