Pilot Study of Swift Microwave Device for Onychomycosis
Onychomycosis of Toenail
About this trial
This is an interventional treatment trial for Onychomycosis of Toenail focused on measuring tinea unguium, dermatophyte
Eligibility Criteria
Inclusion Criteria: Provide written informed consent. Aged 18 years and above. Not Pregnant or breast feeding. Distal subungual onychomycosis (DSO) in a great toenail. One great toenail as a target for treatment having at least 25% involvement of the nail area and no more than 50% involvement of the nail area. Target toenail thickness 1.5mm or less. No area of infection < 3mm from the proximal nail fold. Toenail for treatment with fungal infection confirmed by a positive culture demonstrating the growth of a dermatophyte (i.e. Trichophyton rubrum). No more than 4 toenails showing visual signs of onychomycosis, including the target toenail. Subject agrees not to have any oral antifungal treatment or topical onychomycosis treatment during the study. Able to perform study assessments. Exclusion Criteria: Proximal subungual onychomycosis (PSO). Superficial white onychomycosis (SWO). 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'). Nails infected by rare fungal species or non-fungal organisms such as mould or bacteria "Spike" of onychomycosis extending to <3mm from the eponychium (proximal nail fold) of the target toenail. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail. Patients diagnosed with Diabetes Mellitus (types I and II). Peripheral vascular disease. Recurrent cellulitis. Lymphatic insufficiency. Immunocompromised (due to underlying medical disorders or to immunosuppressive treatments). Exhibit an increased risk of bacterial infections due to skin breakdown induced by a fungus 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. Nails for treatment involving the lunula. Co-morbidities including psoriasis, lichen planus or other medical conditions known to induce nail changes. Patients with trauma from ill-fitting shoes, running or overly-aggressive nail care. Subjects that have podiatric/ nursing nail care on a regular basis. Previous target toenail surgery with any residual disfigurement. Nails infected with Candida. Any uncontrolled condition which, in the opinion of the Investigator, may put the subjects at undue risk of adverse effects during the study. Subjects who have had any topical onychomycosis medication for at least 6-months prior to start of treatment or oral antifungal medication at least 12-months prior to study treatment. Implantable Cardioverter Defibrillator (ICD), pacemaker or other implantable device. Metal implants at the site of treatment (within foot or ankle). Severe moccasin tinea pedis. Known allergy or intolerance to microwave therapy. 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. Current participation in a non-observational trial, or have done so within the last 30-days.
Sites / Locations
- Mediprobe Research IncRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group A-Weekly x 4wk
Group B-Biweekly x4wk
Group C-Biweekly x 24wks
Subjects will receive treatment on Day 0 and then weekly in the first month followed by monthly treatment to Month 6 (9 treatments). Subjects who do not meet the 'temporary increase in clear nail' criteria at Month 6 and/or Month 9 will be offered once monthly treatment for 3 additional months.
Subjects will receive treatment on Day 0 and then every two weeks in the first month followed by monthly treatment to Month 6 (7 treatments). Subjects who do not meet the 'temporary increase in clear nail' criteria at Month 6 and/or Month 9 will be offered once monthly treatment for 3 additional months.
Subjects will receive treatment on Day 0 and then once every two weeks in the first six months (12 treatments). Subjects who do not meet the 'temporary increase in clear nail' criteria at Month 6 and/or Month 9 will be offered once monthly treatment for 3 additional months.