Based on these preliminary results, this study has been designed to demonstrate the efficacy and safety of the PinPointe FootLaser for clearing toenails, including those with onychomycosis. Preliminary in vitro and in vivo work has demonstrated the proof of principle that the PinPointe FootLaser device can kill microorganisms, including dermatophytes and other fungi, which infect the toenail. Dermatophyte infections are common worldwide. The main causative agent varies according to climate. Importantly, it is a particular problem that disproportionately affects diabetics. A recent European study showed that the prevalence of onychomycosis may be as high as 26.9%. It is estimated that there are more than 40 million sufferers with this condition in the USA. Onychomycosis (OM), a fungal infection of the toes, is a major health problem around the world. It received pre-market Section 510(k) clearance by the FDA and subsequent clearance for the treatment of onychomycosis in 2010. It is a pulsed Nd:Yag laser device that uses a proprietary pulse train, operating at 1064nm wavelength, with 100 μsec pulses. We are proud to be the first medical office in Orange. The medical device that is the subject of this clinical trial is the PinPointe FootLaser, manufactured by NuvoLase, Inc. The PinPointe Laser is a clinically proven laser device to treat toenail and fingernail fungal infections. The cumulative cure rate of laser treatment was significantly higher for CO 2 lasers than other types of laser. Enrollment is competitive and we expect to enroll 40 patients at CHA. Laser treatment of onychomycosis is effective and safe. The duration of enrollment for each subject will be 2 years, with the expectation that this is the time period that will yield 100% reduction in the area of involved nail. This protocol is designed to demonstrate that the PinPointe FootLaser treatment is able to produce clinical improvement treating onychomycosis in patients who have previously taken Terbinafine and failed treatment. Why Should I Register and Submit Results?.
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