Wound being healed by soft light

Can Light Therapy Heal Chronic Wounds? The EUREKA Trial's Promising Results

"Fluorescence biomodulation offers new hope for patients suffering from stubborn venous leg ulcers, diabetic foot ulcers, and pressure ulcers. Discover the EUREKA trial's findings."


Chronic wounds, including venous leg ulcers (VLUs), diabetic foot ulcers (DFUs), and pressure ulcers (PUs), pose a significant challenge for healthcare professionals worldwide. These wounds often resist conventional treatments, leading to prolonged suffering and reduced quality of life for patients. But a new approach is showing real promise.

Fluorescence biomodulation (FB), a type of photobiomodulation (PBM) also known as low-energy level light (LELL), is emerging as a valuable tool in wound care. FB uses specific wavelengths of light to stimulate cells and accelerate the natural healing process. The EUREKA (EvalUation of Real lifE use of Klox biophotonic system in chronic wound mAnagement) trial was designed to investigate how well FB works in real-world settings.

The EUREKA trial focused on the LumiHeal system, which utilizes FB to treat chronic wounds. Researchers aimed to confirm its effectiveness and safety for VLUs, DFUs, and PUs. By examining how FB affects wound healing, the study hoped to provide new insights into managing these challenging conditions.

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Current Wound-Care Strategies

A September 2025 review describes chronic wound healing as complex and identifies limitations in current therapeutic approaches. It highlights chemical strategies such as pH modulation, biomaterials, and gas-mediated therapies, alongside physical strategies including electrical stimulation, photothermal therapy, and mechanotransduction. The EUREKA trial evaluated fluorescence biomodulation, a form of photobiomodulation also known as low energy level light, as a clinical tool for wounds that remained recalcitrant to treatment. Its reported findings describe positive efficacy across three types of hard-to-heal chronic wounds, with treatment considered safe and well tolerated and associated with improved quality of life.

From Light Therapy to PBM

A 2026 review places chronic wounds, including diabetic and venous ulcers, pressure injuries, and severe burns, within a worldwide burden affecting patients' quality of life and healthcare systems. Photobiomodulation is described as a non-invasive therapy using specific wavelengths, typically in the red and near-infrared spectrum, to stimulate cellular processes and promote healing. Research published in 2021 reports that PBM can provide therapeutically significant benefits in chronic-wound healing, which becomes disrupted when healing stages fail to progress in a timely and orderly manner.

EUREKA Trial: A Beacon of Hope for Chronic Wound Sufferers

Wound being healed by soft light

The EUREKA trial, a multi-center, prospective, observational, uncontrolled study conducted across 12 clinical sites in Italy, enrolled 100 subjects, with the final analysis including 99 patients. Participants had various chronic wounds: 52 VLUs, 32 DFUs, and 15 PUs. The study combined FB treatment with standard of care (SoC) specific to each wound type.

Researchers used the LumiHeal system, applying a chromophore gel to the wound and then illuminating it with an LED activator. Wound area was assessed using the Silhouette Imaging System, and quality of life (QoL) was measured using the Cardiff Wound Impact Schedule (CWIS). Clinicians also provided feedback on the system's usability.

  • Significant Wound Closure: Total wound closure was achieved in 47 patients: 26 VLUs (50%), 16 DFUs (50%), and 5 PUs (33.3%).
  • Reduced Wound Area: The mean wound area regression was significant for VLUs (41.0%) and DFUs (52.4%).
  • Predictive Healing: Ulcer response to treatment could be predicted after four weeks.
  • High Adherence: Patient adherence to the treatment was high (95.2%).
  • Improved Quality of Life: Significant improvements in QoL were reported, with a 15.4% increase in the CWIS total score.
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Recent Evidence Across Therapies

Recent literature reviews several approaches to difficult-to-heal wounds. One review reports that rituximab was effective in 43.75% of cases, followed by tocilizumab at 25%, and etanercept and adalimumab at 18.75% each, while describing monoclonal antibodies as having therapeutic potential for chronic wounds unresponsive to standard treatments. A systematic review of LED phototherapy in people with diabetes notes that pressure ulcers took approximately twice as long to heal completely as diabetic ulcers, even though neuropathy and angiopathy may contribute to low healing rates. Separate fluorescence-biomodulation research reports reduced inflammation and more physiologic re-epithelialization and collagen remodeling in acute incisional wounds, as well as accelerated healing and improved quality of life in patients with hard-to-heal chronic ulcers.

Important Study Limitations

The interim EUREKA analysis has methodological limitations that affect how its findings should be interpreted. Because the study aimed to assess the BioPhotonic gel in a real-life setting across different investigating centers, it did not include a formal sample-size calculation for each group. It also had no control group, limiting direct comparison with standard care or other treatments. These design constraints mean the reported efficacy cannot by itself establish comparative treatment effectiveness.

Fluorescent Light Versus Standard Care

A retrospective comparison of biomodulation induced by fluorescent light energy with standard care in venous leg ulcers reported better outcomes for the EUREKA group than for its matched comparison group. By 16 weeks, full wound closure was reported in 40% of EUREKA cases versus 7% in the matching group. Separate PBM research describes potential for augmenting adipose-derived stem-cell-mediated tissue repair and chronic wound healing, but emphasizes that further mechanistic and clinical studies are needed to clarify molecular pathways and optimize treatment parameters.

The EUREKA trial confirmed that FB has a positive effect on the wound healing process across different types of chronic wounds. It demonstrated that the treatment is safe, well-tolerated, and significantly improves patient QoL.

The Future of Wound Care: Light at the End of the Tunnel?

The EUREKA trial offers compelling evidence for the use of fluorescence biomodulation as a valuable tool in the management of chronic wounds. By promoting healing, improving quality of life, and demonstrating a strong safety profile, FB holds significant promise for patients who have struggled with persistent wounds. As research continues, FB may become an increasingly important part of comprehensive wound care strategies.

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What the EUREKA Evidence Suggests

The EUREKA research was conducted as a multicenter, prospective, observational, uncontrolled trial across 12 clinical sites in Italy. Its reported conclusions describe a positive efficacy profile for LumiHeal® in inducing healing in three different types of hard-to-heal chronic wounds. The same report states that treatment was safe and well tolerated and that patient quality of life improved statistically significantly. Because the study was uncontrolled, these encouraging findings support further evaluation rather than proving that fluorescence biomodulation alone heals chronic wounds.

The treatment schedule and safety findings in context

  • 2 mmThe chromophore gel was applied in a 2 mm layer after saline cleansing, on a biweekly schedule; the report does not make this schedule a comparison with other schedules.[1]

The EUREKA trial of LumiHeal in chronic wounds

Study designObservational study[1]
Sample size100 enrolled; final analysis included 99 patients/ulcers[1]
Setting12 clinical sites in Italy[1]
Main outcomeEfficacy and safety of LumiHeal in treating chronic wounds[1]
Effect sizeTotal wound closure in 47 patients: 26 VLUs (50%), 16 DFUs (50%), and five PUs (33.3%); mean area regression 41.0% for VLUs and 52.4% for DFUs[1]
p-valuep<0.001[1]
Times cited40[1]

Questions the EUREKA findings leave open

  • Would the observed outcomes differ from those under standard care alone in a controlled comparison?[1]

About this Article -

Written with AI assistance from published research, and reviewed by the Mystum team. See our About page for more information.

This article is based on research published under:

DOI-LINK: 10.12968/jowc.2018.27.11.744, Alternate LINK

Title: Evaluation Of Fluorescence Biomodulation In The Real-Life Management Of Chronic Wounds: The Eureka Trial

Subject: Nursing (miscellaneous)

Journal: Journal of Wound Care

Publisher: Mark Allen Group

Authors: Marco Romanelli, Alberto Piaggesi, Giovanni Scapagnini, Valentina Dini, Agata Janowska, Elisabetta Iacopi, Carlotta Scarpa, Stéphane Fauverghe, Franco Bassetto

Published: 2018-11-02

Everything You Need To Know

1

What is fluorescence biomodulation (FB), and how does it aid in healing chronic wounds like venous leg ulcers, diabetic foot ulcers, and pressure ulcers?

Fluorescence biomodulation (FB) is a form of photobiomodulation (PBM), also known as low-energy level light (LELL), that uses specific wavelengths of light to stimulate cells and accelerate the natural healing process. It's being explored as a treatment for chronic wounds like venous leg ulcers (VLUs), diabetic foot ulcers (DFUs), and pressure ulcers (PUs) because these wounds often resist conventional treatments. FB offers a way to promote healing in these persistent conditions.

2

Can you explain the EUREKA trial and its significance in the context of chronic wound treatment using the LumiHeal system?

The EUREKA (EvalUation of Real lifE use of Klox biophotonic system in chronic wound mAnagement) trial was a multi-center, prospective, observational study conducted across 12 clinical sites in Italy, involving 100 subjects with chronic wounds like venous leg ulcers, diabetic foot ulcers, and pressure ulcers. It aimed to evaluate the effectiveness and safety of fluorescence biomodulation (FB), delivered via the LumiHeal system, in real-world clinical settings when combined with standard of care (SoC) treatments. The trial's significance lies in its demonstration of FB's positive impact on wound healing, safety, tolerability, and improvement of patient quality of life, offering a promising alternative for those struggling with persistent wounds.

3

What were the key findings of the EUREKA trial regarding the treatment of venous leg ulcers (VLUs), diabetic foot ulcers (DFUs), and pressure ulcers (PUs) using fluorescence biomodulation (FB)?

The EUREKA trial reported that fluorescence biomodulation (FB) had a positive effect on the wound healing process for various types of chronic wounds. Specifically, total wound closure was achieved in 50% of venous leg ulcer (VLU) cases and 50% of diabetic foot ulcer (DFU) cases, and 33.3% of pressure ulcers (PUs). Additionally, there was a significant mean wound area regression for VLUs (41.0%) and DFUs (52.4%). The trial also showed that ulcer response to treatment could be predicted after four weeks, patient adherence to the treatment was high at 95.2%, and significant improvements in quality of life were reported, with a 15.4% increase in the Cardiff Wound Impact Schedule (CWIS) total score.

4

How does the LumiHeal system work in applying fluorescence biomodulation (FB) for treating chronic wounds, and what role does the chromophore gel play in this process?

The LumiHeal system applies fluorescence biomodulation (FB) by first applying a chromophore gel to the chronic wound, such as a venous leg ulcer, diabetic foot ulcer or a pressure ulcer. After the gel is applied, the wound is illuminated with an LED activator. This process allows the specific wavelengths of light, that are part of fluorescence biomodulation, to stimulate the cells and accelerate the natural healing process. The chromophore gel enhances the effectiveness of the light by making the cells more receptive to the light energy.

5

Beyond the specifics of wound closure and area reduction, what implications does the EUREKA trial's finding of improved Quality of Life (QoL) have for patients with chronic wounds treated with fluorescence biomodulation (FB)?

The EUREKA trial's finding of improved Quality of Life (QoL), as indicated by a 15.4% increase in the Cardiff Wound Impact Schedule (CWIS) total score, has significant implications for patients with chronic wounds treated with fluorescence biomodulation (FB). Chronic wounds like venous leg ulcers, diabetic foot ulcers and pressure ulcers often cause pain, discomfort, social isolation, and psychological distress, severely impacting a patient's overall well-being. Therefore, beyond just physical healing, the ability of FB to enhance QoL suggests that this treatment can address the broader, more holistic needs of patients, enabling them to regain a sense of normalcy, improve their mental health, and engage more fully in daily activities.

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