EUREKA study – the evaluation of real-life use of a biophotonic system in chronic wound management: an interim analysis
Authors Romanelli M, Piaggesi A, Scapagnini G, Dini V, Janowska A, Iacopi E, Scarpa C, Fauverghe S, Bassetto F
Received 25 May 2017
Accepted for publication 17 October 2017
Published 11 December 2017 Volume 2017:11 Pages 3551—3558
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Ashok Kumar Pandurangan
Peer reviewer comments 3
Editor who approved publication: Dr Tuo Deng
Marco Romanelli,1 Alberto Piaggesi,2 Giovanni Scapagnini,3 Valentina Dini,1 Agata Janowska,1 Elisabetta Iacopi,2 Carlotta Scarpa,4 Stéphane Fauverghe,5 Franco Bassetto4
1Wound Healing Research Unit, Division of Dermatology, School of Medicine, University of Pisa, Pisa, 2Diabetic Foot Section, Department of Medicine, University of Pisa, Pisa, 3Department of Medicine and Health Sciences, School of Medicine, University of Molise, Campobasso, 4Clinic of Plastic and Reconstructive Surgery, Padova University-Hospital, Padova, Italy; 5KLOX Technologies Inc., Laval, QC, Canada
Objective: Interest has grown regarding photobiomodulation (PBM) with low-level light therapy, which has been shown to positively affect the stages of the wound healing process. In a real-life context clinical setting, the objective of the EUREKA study was to investigate efficacy, safety, and quality of life associated with the use of a BioPhotonic gel (LumiHeal™) in the treatment of chronic wounds such as venous leg ulcers (VLUs), diabetic foot ulcers (DFUs), and pressure ulcers (PUs). This BioPhotonic gel represents a new, first-in-class emission spectrum of light, including fluorescence, to induce PBM and modulate healing.
Design: The multicenter, prospective, interventional, uncontrolled, open-label study enrolled 100 patients in 12 wound centers in Italy. We performed an early interim analysis based on the first 33 subjects (13 VLU, 17 DFU, 3 PU) in seven centers who completed the study.
Main results: Seventeen patients (52%) achieved total wound closure (full re-epithelialization for 2 weeks) during the study period. Two patients (6%) were considered “almost closed” (decrease of the wound area of more than 90% at study end) and three others (9%) were considered “ready for skin grafting”. No related serious adverse events were observed, and the compliance was excellent. After the treatment, the average time to “pain-free” was 11.9 days in the VLU group. Quality of life was improved with overall increase of 26.4% of the total score (Cardiff Wound Impact Schedule, p=0.001).
Conclusion: The study revealed a positive efficacy profile of the BioPhotonic gel in promoting wound healing and reactivating the healing process in different types of chronic, hard-to-heal wounds. The treatment was shown to be safe and well tolerated by the patients, and a reduction of pain perception was also detected during the treatment period. The improvement of the quality of life was accompanied by a high level of clinician satisfaction.
Keywords: photobiomodulation, fluorescence biomodulation, biophotonics, phototherapy, light, venous leg ulcers, VLUs, pressure ulcers, PUs, diabetic foot ulcers, DFUs, hard-to-heal wounds
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