Investigating the treatment of fungal nail infections with a novel medical device

Not Applicable

Completed

• Conditions: Onychomycosis; Infections and Infestations; Tinea unguium

• Registration Number: ISRCTN17865863
• Lead Sponsor: Solent NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-08
• Study Completion: 2018-12-31
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

1. Participants < 18 years old
2. 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 <25% or >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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Measured at 1, 3, 6, 9 and 12 months after treatment:<br> 1. Clear nail growth: measuring the distance of the visible infection from the lunula and comparing the measurement to the baseline measurement<br> 2. Mycological cure: determined by laboratory tests (microscopy and culture of the nail samples)<br>

Secondary Outcome Measures

Name	Time	Method
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.