Pilot Study of Swift Microwave Device for Onychomycosis

Launched by MEDIPROBE RESEARCH INC. · Dec 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the Swift Microwave Device to help people with toenail fungus, specifically a type known as onychomycosis. The trial will compare three different microwave treatment frequencies to see which one works best and is the safest. If you are an adult aged 18 or older, have a fungal infection affecting the big toe with a specific level of nail involvement, and can agree to follow certain guidelines, you may be eligible to participate.

Participants will receive microwave treatments and will have their progress monitored over the next year. If someone does not see improvement after the first six months, they may be offered additional treatments to enhance their results. Throughout the study, participants must avoid certain other treatments for toenail fungus and will undergo assessments to determine how well the microwave device is working. It’s a chance to potentially benefit from a new approach to treating toenail fungus while helping researchers learn more about its effectiveness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Provide written informed consent.
• • 2. Aged 18 years and above.
• • 3. Not Pregnant or breast feeding.
• • 4. Distal subungual onychomycosis (DSO) in a great toenail.
• • 5. One great toenail as a target for treatment having at least 20% involvement of the nail area and no more than 75% involvement of the nail area.
• • 6. Target toenail thickness 3mm or less.
• • 7. No area of infection \< 3mm from the proximal nail fold.
• • 8. Toenail for treatment with fungal infection confirmed by detection of a dermatophyte organism (i.e. Trichophyton rubrum).
• • 9. No more than 4 toenails showing visual signs of onychomycosis, including the target toenail.
• • 10. Subject agrees not to have any oral antifungal treatment or topical onychomycosis treatment during the study.
• • 11. Able to perform study assessments.
• Exclusion Criteria:
• • 1. Proximal subungual onychomycosis (PSO).
• • 2. Superficial white onychomycosis (SWO).
• • 3. Nail changes that appear as parallel lines, small pinpoint depressions, brown spots, black or brown linear streaks, complete yellowing of all nails without textural change, green debris below the nail or notches in the nail margin ('non-onychomycotic dystrophy').
• • 4. Nails infected by rare fungal species or non-fungal organisms such as mould or bacteria
• • 5. "Spike" of onychomycosis extending to \<3mm from the eponychium (proximal nail fold) of the target toenail.
• • 6. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
• • 7. Patients diagnosed with Diabetes Mellitus (types I and II).
• • 8. Peripheral vascular disease.
• • 9. Recurrent cellulitis.
• • 10. Lymphatic insufficiency.
• • 11. Immunocompromised (due to underlying medical disorders or to immunosuppressive treatments).
• • 12. Exhibit an increased risk of bacterial infections due to skin breakdown induced by a fungus
• • 13. Have a current infection or condition of the feet (fungal or otherwise) which may require antifungal or antibacterial treatment during therapy that may confound the study data.
• • 14. Nails for treatment involving the lunula.
• • 15. Co-morbidities including psoriasis, lichen planus or other medical conditions known to induce nail changes.
• • 16. Patients with trauma from ill-fitting shoes, running or overly-aggressive nail care.
• • 17. Subjects that have podiatric/ nursing nail care on a regular basis.
• • 18. Previous target toenail surgery with any residual disfigurement.
• • 19. Nails infected with Candida.
• • 20. Any uncontrolled condition which, in the opinion of the Investigator, may put the subjects at undue risk of adverse effects during the study.
• • 21. Subjects who have had any topical onychomycosis medication for at least 3-months prior to start of treatment or oral antifungal medication at least 6-months prior to study treatment.
• • 22. Implantable Cardioverter Defibrillator (ICD), pacemaker or other implantable device.
• • 23. Metal implants at the site of treatment (within foot or ankle).
• • 24. Severe moccasin tinea pedis.
• • 25. Known allergy or intolerance to microwave therapy.
• • 26. Subject who has had any topical metallic or ionic treatment (e.g, aluminum chloride, silver nitrate) in the target or treated toenail areas within the last 6 months and agrees not to use any during the study.
• • 27. Current participation in a non-observational trial, or have done so within the last 30-days.