Clinical dosimetry and efficacy of LED photobiomodulation for chronic lower-limb wound healing: a systematic review of randomized trials

Clinical Snapshot

Key Findings

• P Value: Not reported in aggregate; individual trial-level significance data not synthesised in the abstract

• Effect Size: No pooled effect size calculable; narrative synthesis suggests a positive directional trend for wound area reduction and wound bed quality, particularly in diabetic foot ulcers, across the majority of included trials

• Primary Outcome: Wound area reduction, wound bed quality improvement, and microcirculation enhancement in chronic lower-limb wounds treated with LED photobiomodulation

• Nnt Or Sensitivity: NNT not calculable from available data; the dose-response signal (126 J/cm² showing no benefit vs. lower energy densities showing positive trends) is the most clinically actionable quantitative observation, suggesting an upper threshold effect

• Confidence Interval: Not reported — no meta-analysis performed; quantitative precision of effect estimates is unavailable

Clinical Application

LED photobiomodulation devices are commercially available, relatively low-cost compared to advanced wound care technologies, and can be administered in outpatient, community, or home settings. The noninvasive nature and favourable safety profile reported across included trials support feasibility. However, the absence of standardised dosimetric protocols is a major barrier to consistent clinical implementation. Clinicians would need to select wavelength and energy density parameters without robust evidence-based guidance. Chronic lower-limb wounds, particularly diabetic foot ulcers, represent a substantial burden in Australia, with the Australian Institute of Health and Welfare estimating significant healthcare costs and hospitalisation rates associated with diabetic foot disease. LED photobiomodulation devices are not currently listed on the Pharmaceutical Benefits Scheme (PBS) and are not specifically endorsed in RACGP or Australian Diabetes Society guidelines for wound management. The TGA regulates LED photobiomodulation devices as Class IIa medical devices, and several are listed on the ARTG. However, the current evidence base (GRADE: very low certainty) does not support routine clinical use or MBS item number justification. Allied health professionals (podiatrists, wound care nurses, physiotherapists) may encounter these devices in private practice settings. Clinicians should counsel patients that while the therapy appears safe, evidence of efficacy remains preliminary and standardised treatment protocols are lacking. Participation in well-designed Australian RCTs would be the most appropriate pathway to advancing this evidence base. Adults with chronic lower-limb wounds, particularly diabetic foot ulcers, venous leg ulcers, and pressure injuries of the lower extremity who have failed or are receiving standard wound care. Patients with contraindications to photobiomodulation (active malignancy over treatment area, photosensitising medications) should be excluded.

Abstract

Chronic lower-limb wounds represent a major clinical and socioeconomic burden due to delayed healing and high recurrence rates. Light-emitting diode (LED) photobiomodulation has been proposed as a noninvasive and low-cost adjunctive therapy; however, clinical evidence remains inconsistent. This systematic review aimed to synthesize evidence from randomized clinical trials investigating the efficacy of LED photobiomodulation for chronic lower-limb wound healing and to identify irradiation parameters associated with improved outcomes. A comprehensive search was conducted in PubMed, Scopus, Web of Science, and Embase up to May 2026. Six randomized clinical trials met the inclusion criteria. Wavelengths ranged from 620 to 950 nm, and energy densities varied between 2.4 and 126 J/cm². The findings suggest that LED photobiomodulation may promote wound area reduction, improve wound bed quality, and increase microcirculation, particularly in diabetic foot ulcers. However, one study using a high energy density (126 J/cm²) did not demonstrate beneficial effects, suggesting a possible dose-dependent response. The overall certainty of the evidence, assessed using the GRADE approach, was classified as very low due to inconsistency and indirectness among the included studies. Although LED photobiomodulation appears to be safe and demonstrates therapeutic potential, substantial heterogeneity in irradiation parameters, small sample sizes, and methodological limitations preclude definitive conclusions regarding its clinical efficacy. Well-designed randomized controlled trials with standardized protocols and dose-response investigations are needed to establish optimal therapeutic parameters and confirm clinical efficacy.

References

1. 1.Miranda, M. B., Barros, A. C. S., de Paula, A. V. L., Alves, R. F., da Rocha, R. B., & Cardoso, V. S. (2026). Clinical dosimetry and efficacy of LED photobiomodulation for chronic lower-limb wound healing: a systematic review of randomized trials. Lasers in Medical Science. https://doi.org/10.1111/iwj.13540