Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2011-10-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Diode Laser Treatment
Diode Laser Treatment
Laser treatment once every 6 weeks, for a total of 4 treatment sessions
Interventions
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Diode Laser Treatment
Laser treatment once every 6 weeks, for a total of 4 treatment sessions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fitzpatrick Skin Type I-IV
* Written and verbal informed consent
* Able to comply with study instructions and to return to the clinic for required visits
* Agrees to refrain from other active topical, laser or light-based treatment to the great toes
* Agrees to the use of Naftin Gel between the toes to prevent/control tinea pedis
Exclusion Criteria
* History of cutaneous photosensitivity, porphyria and hypersensitivity to porphyrins or photodermatoses
* Any skin pathology or condition that could interfere with the evaluation or that requires the use of interfering topical or systemic therapy
* Coagulation disorder or current use of anti-coagulation medication (including aspirin use of greater than 81 mg per day)
* Any condition which, in the investigator's opinion, would make it unsafe for the subject to participate
* Enrolled in an investigational drug or device trial, or has been treated with an investigational device or received an investigational drug within 30 days
* Oral Lamisil within 1 year, Sporanox or over-the-counter topicals within 1 month, or other prescription anti-fungal medications or topicals within 6 months
* Evidence of diabetic neuropathy or peripheral vascular disease related to diabetes, or a loss of protective sensation in the affected foot
* Psoriasis, lichen planus, infection involving the lunula, prior surgical treatment of the affected great toe within 1 year, or a history of trauma to the affected great toe
* Immunocompromised status, or with existing (or history of) cancer/skin malignancy
* Distal nail thickness of greater than 2mm in the affected great toenail
18 Years
80 Years
ALL
No
Sponsors
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ConBio, a Cynosure Company
INDUSTRY
Responsible Party
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Principal Investigators
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Darren Courtright, DPM
Role: PRINCIPAL_INVESTIGATOR
Shoreline Foot and Ankle Center
Locations
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Shoreline Foot and Ankle Center
New London, Connecticut, United States
Shoreline Foot and Ankle Center
Westbrook, Connecticut, United States
Countries
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Other Identifiers
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D4-11-F
Identifier Type: -
Identifier Source: org_study_id