Evaluation of fluorescence biomodulation in the real-life management of chronic wounds: the EUREKA trial

Abstract

Objective: Fluorescence biomodulation (FB), a form of photobiomodulation (PBM) that is also known as low energy level light (LELL), has become an increasingly used clinical tool to induce wound healing in wounds that remain recalcitrant to treatment. In a real-life clinical setting, the aim of the EUREKA (EvalUation of Real-lifE use of Klox biophotonic system in chronic wound mAnagement) study was to confirm the efficacy and safety of LumiHeal, a system based on FB, in the treatment of chronic wounds such as venous leg ulcers (VLUs), diabetic foot ulcers (DFUs) and pressure ulcers (PUs). The effects of this FB system on the modulation of wound healing in chronic ulcers through FB induction were previously examined in an interim analysis of this study. Method: A multicenter, prospective, observational, uncontrolled trial in 12 clinical sites in Italy. The wound was cleansed with saline and a 2mm thick layer of a chromophore gel was applied to the affected area in a biweekly regimen. The area was then illuminated with the LED activator for five minutes at a distance of 5cm. Treatment was used in combination with standard of care specific to each type of chronic wound (VLU, DFU, PU). Wound area evaluation was assessed using the Silhouette Imaging System and quality of life (QoL) with the Cardiff Wound Impact Schedule (CWIS). A seven-point evaluation of the clinicans' view was also examined. Results: We enrolled 100 subjects, with the final analysis including 99 patients/ulcers consisting of 52 VLUs, 32 DFUs and 15 PUs. Total wound closure at the end of the study was achieved in 47 patients by aetiology: 26 VLUs (50% of VLUs); 16 DFUs (50% of DFUs); and five PUs (33.3% of PUs). The mean wound area regression at last study assessment was significant for VLUs (41.0%; p<0.001) and DFUs (52.4%; p<0.001). After four weeks of treatment, it was possible to significantly predict if the ulcer would respond (defined as a decrease of wound size) to the study treatment. Adherence was high (95.2%) and no related serious adverse events were reported during the study. QoL significantly improved, with an increase of 15.4% of the total score, using the CWIS (p<0.001). Conclusion: The study confirmed a positive efficacy profile of the FB system in inducing the wound healing process in three different types of hard-to-heal chronic wounds. The treatment was shown to be safe and well tolerated by the patients, with a significant improvement in patient QoL. This approach offers an effective modality for the treatment of hard-to-heal chronic ulcers.

Management of otitis externa with an led-illuminated gel: a randomized controlled clinical trial in dogs

“…The lack of significant statistical differences between groups in the clinical secondary outcomes (Pruritus Severity Scale; Pain Severity Score; Aural temperature) helps demonstrate that LIG can have at least an equivalent clinical effect to the standard of care chosen. These results are very encouraging and well in line with the previous results reported with FB systems in humans suffering from diseases of QW group receiving LIG once weekly, BW group receiving LIG twice weekly, C group receiving standard of care twice daily, sd standard deviation, T 0 first evaluation time, T 5 sixth (last) evaluation time the skin, capable of accelerating healing, with reduced pain, and minimizing the clinical signs of bacterial colonization [22,29,32,[46][47][48][49][50]. Poly-microbial colonization often occurs in otitis externa and the continuum between mild-moderate colonization and the beginning of infection are blurred [51][52][53].…”

“…In this context, photobiomodulation (PBM) is widely known for its therapeutic benefits in the protection and regeneration of tissues [18][19][20][21][22][23]. Studies have demonstrated that PBM can reduce pain and inflammation [23][24][25], improve cancer management [26], and stimulate healing and tissue repair [20][21][22][27][28][29][30][31]. PBM is defined by the use of visible light to stimulate biological functions in a non-thermal and non-cytotoxic manner.…”

“…Fluorescence biomodulation (FB), a form of PBM that uniquely employs fluorescence light energy (FLE), has been demonstrated to advance healing of both acute and chronic wounds [22,[29][30][31]33]. A study has demonstrated that acute incisional wounds have reduced inflammation, as well as more physiologic re-epithelization and collagen remodelling, resulting in better quality and less visible scars [21].…”

“…A study has demonstrated that acute incisional wounds have reduced inflammation, as well as more physiologic re-epithelization and collagen remodelling, resulting in better quality and less visible scars [21]. In a multicenter, observational, uncontrolled trial, patients with hard-to-heal chronic ulcers experienced accelerated healing and improved quality of life [22].…”

Fluorescence biomodulation in the management of canine interdigital pyoderma cases: a prospective, single‐blinded, randomized and controlled clinical study

“…One pilot study of five dogs reported the beneficial effects of low‐level laser therapy (a form of PBM) in sterile pyogranulomatous pododermatitis cases; a larger study failed to report an improvement in pedal pruritus and pedal lesions scores in atopic dogs . The KLOX Fluorescence Biomodulation System (KFBS) consists of a blue light‐emitting diode (LED) device and a topical photoconverter gel, which when illuminated by the LED device, emits low‐energy light in the form of fluorescence . In vivo and in vitro studies have shown that KBFS can modulate inflammatory mediators [such as tumor necrosis factor (TNF)‐α and interleukin (IL)‐6] and stimulate growth factors [such as transforming (TGF)‐ß, fibroblast (FGF), platelet‐derived (PDGF) and vascular endothelial (VEGF) growth factors].…”