Onychomycosis Infections and Infestations Tinea unguium
Conditions
Interventions
Patients are randomised to one of four different treatments with the novel device on the right or the left large toenail. The treated toenail is compared to the untreated control (the other large toen
Sponsors
Solent NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants who can provide informed consent 2. Male or female participants 3. Aged 18-80 4. Mycologically confirmed distal subungual onychomycosis in both hallux toenails with 25 – 75% involvement of the nail area
Exclusion criteria
Exclusion criteria: 1. Participants 80 years old 3. Participants currently being treated for onychomycosis or who have been treated within the past four months using topical drug therapies 4. Participants who have taken oral antifungal agents or had laser treatments in the last 12 months 5. Participants who have been involved in other drug or medical device clinical trials in the past 3 months which may affect the safety or efficacy of this study 6. Participants with ulcerations around the toe nails 7. Participants with total dystrophic onychomycosis involving the lunula/nail matrix 8. Participants with peripheral vascular disease, immune-suppression, loss of sensation in either foot, or with any other medical state which warrants definitive antifungal therapy 9. Participants with 75% onychomycosis involvement of the nail area 10. No use of nail varnish on the toe nails for at least four weeks before the first treatment and for at least four months after the last treatment 11. Participants with proximal subungual onychomycosis 12. Participants with superficial white onychomycosis 13. Participants with psoriasis, lichen planus or other medical condition which has the ability to induce nail changes 14. Participants who cannot communicate competently in English 15. Women of childbearing potential who are, or might be, pregnant at the time of the study enrolment or who plan to become pregnant within three months of the study treatment 16. Participants with a pacemaker, implantable cardiac device, deep brain stimulator, gastric stimulator or any other electrically powered implantable device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at 1, 3, 6, 9 and 12 months after treatment: 1. Clear nail growth: measuring the distance of the visible infection from the lunula and comparing the measurement to the baseline measurement 2. Mycological cure: determined by laboratory tests (microscopy and culture of the nail samples) | — |
Secondary
| Measure | Time frame |
|---|---|
| Onychomycosis severity index (OSI). This is measured by the research podiatrist before treatment and at 1, 3, 6, 9 and 12 months. At each of these time points photographs of the nail are taken and an independent onychomycosis severity index will be given by an independent expert based on the photographs. | — |
Countries
United Kingdom
Contacts
Public ContactDavid Voegeli
Outcome results
None listed