A prospective case series evaluating the safety and efficacy of the Klox BioPhotonic System in venous leg ulcers
Authors Nikolis A, Grimard D, Pesant Y, Scapagnini G, Vezina D
Received 16 January 2016
Accepted for publication 25 June 2016
Published 15 September 2016 Volume 2016:3 Pages 101—111
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Prof. Dr. Marco Romanelli
Andreas Nikolis,1 Doria Grimard,2 Yves Pesant,3 Giovanni Scapagnini,4 Denis Vézina5
1Division of Plastic Surgery, Victoria Park Research Centre, Montreal, 2Q&T Research Chicoutimi, Chicoutimi, 3St-Jerome Medical Research Inc., St-Jerome, Quebec, Canada; 4Department of Medicine and Health Sciences, School of Medicine, University of Molise, Campobasso, Italy; 5Klox Technologies, Laval, Quebec, Canada
Purpose: To investigate the safety and efficacy of the BioPhotonic System developed by Klox Technologies in a case series of ten patients with venous leg ulcers.
Patients and methods: Ten patients with chronic venous leg ulcers, having failed on at least one previous therapy, were enrolled into this case series.
Results: Nine patients were evaluable for efficacy. A response (defined as decrease in wound surface area) was observed in seven patients (77.8%). Of these, four patients (44.4%) achieved wound closure on average 4 months (127.5 days) following the beginning of the treatment. Two patients did not respond to the investigational treatment. Quality of life improved over time throughout the study. Compliance was excellent, with 93.2% of visits completed as per protocol. Safety was unremarkable, with only four treatment-emergent-related adverse events, for which no specific intervention was required.
Conclusion: The BioPhotonic System was shown to be safe and extremely well tolerated. It also demonstrated potential in terms of wound closure, wound surface area decrease, and wound bed preparation.
Keywords: biophotonics, light, photobiomodulation, venous leg ulcers
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