Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis (HECT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Universidad Peruana Cayetano Heredia.
Recruitment status was  Available
Sponsor:
Collaborator:
Tulane University School of Medicine
Information provided by:
Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier:
NCT01277796
First received: January 13, 2011
Last updated: January 14, 2011
Last verified: January 2011

January 13, 2011
January 14, 2011
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Complete list of historical versions of study NCT01277796 on ClinicalTrials.gov Archive Site
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Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis
Pilot Study of Thermotherapy Treatment for Cutaneous Leishmaniasis in Peru With the HECT-CL Device

Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable. Thermotherapy is a clinically validated first line alternative for the treatment of Cutaneous Leishmaniasis in South America. However, current heat-delivery modalities are either too costly or lack governmental approval required to be made widely available to endemic areas. The investigators have adapted a reliable, safe, and low-cost heat pack for Cutaneous Leishmaniasis that the investigators have named the HECT-CL device. In this pilot study the investigators will enroll 25 patients who have either failed or are not candidates for pentivalent antimonies. The hypothesis states that the HECT-CL device demonstrates efficacy non-statistically inferior to estimates for current South American Pentavalent Antimonial cure rates (76%) while demonstrating basic safety and tolerability.

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Expanded Access
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Cutaneous Leishmaniasis
Device: Heat pack conduction-heat therapy
Hand warmer heat pack with reliable (and monitored) temperature (50-52 degrees Celsius) will be applied to lesion borders for 3 minutes (fractionated to 90 second intervals or less) every day, for 7 consecutive days.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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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.
Both
8 Years to 80 Years
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Contact: Alejandro Llanos-Cuentas, MD, PhD 51-1-482-7739 elmer.llanos@upch.pe
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NCT01277796
032-08
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Richard Witzig, MD, MPH, Associate Professor of Medicine., Infectious Diseases Section, Tulane School of Medicine.
Universidad Peruana Cayetano Heredia
Tulane University School of Medicine
Principal Investigator: Alejandro Llanos-Cuentas, MD, PhD Universidad Peruana Cayetano Heredia
Principal Investigator: Witzig Richard, MD, MPH Tulane Medical School
Universidad Peruana Cayetano Heredia
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP