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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01277796 |
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Date of registration:
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13/01/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis
HECT |
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Scientific title:
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Pilot Study of Thermotherapy Treatment for Cutaneous Leishmaniasis in Peru With the HECT-CL Device |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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Recruitment status: |
Available |
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URL:
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http://clinicaltrials.gov/show/NCT01277796 |
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Study type:
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Expanded Access |
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Study design:
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N/A
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Phase:
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N/A
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Contacts
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Name:
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Witzig Richard, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tulane Medical School |
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Name:
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Alejandro Llanos-Cuentas, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad Peruana Cayetano Heredia |
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Name:
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Alejandro Llanos-Cuentas, MD, PhD |
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Address:
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Telephone:
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51-1-482-7739 |
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Email:
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elmer.llanos@upch.pe |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- with CL diagnosed by skin smear (WHO method), biopsy, culture, PCR
- aged 8-80 years old
- with no more than 3 lesions
- ulcerative and non-ulcerative ulcers less than 4 cm diameter.
- allergy, prohibitive side effects to standard chemotherapy, or other contraindication
to antimonial treatment (e.g. cardiac arrhythmia)
- capable of signing an informed consent or having capable guardians (in the case of
minors).
- Children = 8 years of age must give written or verbal informed assent along with
written consent of their guardians.
Exclusion Criteria:
- lesions less than 2cm from the nose, mouth, ears, or eyes.
- clinically diagnosed with mucosal involvement.
- evidence of lymph node involvement on exam.
- unable or unwilling to commit to the treatment and follow-up plan.
- prior CL treatment within last 1 month.
- pregnant or lactating
- uncontrolled severe systemic illness or immunocompromised state.
Age minimum:
8 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cutaneous Leishmaniasis
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Intervention(s)
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Device: Heat pack conduction-heat therapy
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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