Status:
COMPLETED
Evaluation of CL Detect™ Rapid Test to Detect Cutaneous Leishmaniasis
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
InBios International, Inc.
Conditions:
Skin Diseases
Eligibility:
All Genders
18+ years
Brief Summary
This study is a single-site trial assessing the specificity of CL Detect™ Rapid Test versus the gold standard for Leishmania diagnosis in the US which is microscopic identification of Leishmania amast...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Subject is able to give written informed consent
- Subject has a skin ulcer that satisfies the following criteria for an index lesion:
- less than 4 months in age
- primarily ulcerative, not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis
- in a location suitable for collecting samples by dental broach and scraping
- In the opinion of the investigator, the subject is capable of understanding and complying with the protocol
Exclusion
- Received treatment for leishmaniasis or any treatment to the lesion even if not previously diagnosed as leishmaniasis such as azoles, cryotherapy, imiquimod, thermotherapy, photodynamic therapy, within 2 months prior to signing the consent form, with the exception of mercurochrome
Key Trial Info
Start Date :
June 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01865032
Start Date
June 1 2013
End Date
April 1 2014
Last Update
September 8 2014
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029