CAPTOE
Research type
Research Study
Full title
A randomised pilot clinical investigation of a novel plasma device (PF4) with concurrent controls in toenail onychomycosis
IRAS ID
198102
Contact name
Cathy Price
Contact email
Sponsor organisation
Solent NHS Trust
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
Onychomycosis, a fungal infection in any part of a nail, is prevalent in up to 10% of the population. Current drug treatments require months of administration and are not very effective. This study is investigating the use of a tissue tolerant gas plasma to treat onychomycosis in a single (or possibly two) treatments. A gas plasma is an ionised gas (a gas which has an electrical charge placed across it) - these are routinely seen in fluorescent lights. The specific plasma has been designed to operate at temperatures that do not damage normal tissue. Gas plasmas have been used in surface sterilization and wound healing. The novel aspect of this particular plasma device is the data generated shows that when the top surface of the nail is treated the fungus on the underside of the nail will be killed.
It is hoped this will lead to a new treatment option able to be offered to onychomycosis sufferers by podiatrists which is quicker and more effective than existing therapies.
The medical device will be tested in 80 patients who have confirmed onychomycosis in both large toenails. One large toenail will be treated by a podiatrist during a short visit to the study site (with one of four randomised treatment regimes) and the other will remain untreated. Subjects will be reviewed at the study site at 1, 3, 6, 9 and 12 months after treatment and assessed for clearance of the fungal infection in the large toenails and evidence of clear nail growth.
The study is open to patients between 18 and 80 years old who do not have health complications with known impact on foot health or other conditions requiring antifungal treatment or which cause reduced sensitivity in the feet. The study will be undertaken at a single site in the Southampton area.REC name
London - Stanmore Research Ethics Committee
REC reference
16/LO/0671
Date of REC Opinion
19 May 2016
REC opinion
Further Information Favourable Opinion