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The purpose of this study is to evaluate the V-Raser diode laser system with investigational Nail Fungus Handpiece in the treatment of onychomycosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diode Laser Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diode Laser Treatment | Device | Laser treatment once every 6 weeks, for a total of 4 treatment sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Clear Nail Growth from Baseline in mm or as measurement of total area of involvement | Amount of lesion-free toenail growth (mm or total area of involvement) from Baseline, as judged by computer software analysis of photos. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darren Courtright, DPM | Shoreline Foot and Ankle Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shoreline Foot and Ankle Center | New London | Connecticut | 06320 | United States | ||
| Shoreline Foot and Ankle Center |
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| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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Even though this study has recruited more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial.
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| Westbrook |
| Connecticut |
| 06498 |
| United States |
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |