Title |
EUREKA study – the evaluation of real-life use of a biophotonic system in chronic wound management: an interim analysis
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Published in |
Drug Design, Development and Therapy, December 2017
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DOI | 10.2147/dddt.s142580 |
Pubmed ID | |
Authors |
Marco Romanelli, Alberto Piaggesi, Giovanni Scapagnini, Valentina Dini, Agata Janowska, Elisabetta Iacopi, Carlotta Scarpa, Stéphane Fauverghe, Franco Bassetto |
Abstract |
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. 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. 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). 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. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 179 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Bachelor | 34 | 19% |
Student > Master | 17 | 9% |
Other | 13 | 7% |
Researcher | 11 | 6% |
Professor | 9 | 5% |
Other | 26 | 15% |
Unknown | 69 | 39% |
Readers by discipline | Count | As % |
---|---|---|
Nursing and Health Professions | 51 | 28% |
Medicine and Dentistry | 24 | 13% |
Agricultural and Biological Sciences | 8 | 4% |
Biochemistry, Genetics and Molecular Biology | 5 | 3% |
Psychology | 3 | 2% |
Other | 13 | 7% |
Unknown | 75 | 42% |