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Trial record 1 of 2 for:    heat pack leishmaniasis
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Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis (HECT)

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ClinicalTrials.gov Identifier: NCT01277796
Expanded Access Status : Available
First Posted : January 17, 2011
Last Update Posted : January 17, 2011
Sponsor:
Collaborator:
Tulane University School of Medicine
Information provided by:
Universidad Peruana Cayetano Heredia

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Cutaneous Leishmaniasis Device: Heat pack conduction-heat therapy

Study Design
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Study Type : Expanded Access
Official Title: Pilot Study of Thermotherapy Treatment for Cutaneous Leishmaniasis in Peru With the HECT-CL Device

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leishmaniasis

Interventions
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Intervention Details:
  • 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.
Eligibility Criteria
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Ages Eligible for Study:   8 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277796


Contacts
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Contact: Alejandro Llanos-Cuentas, MD, PhD 51-1-482-7739 elmer.llanos@upch.pe

Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
Tulane University School of Medicine
Investigators
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Principal Investigator: Alejandro Llanos-Cuentas, MD, PhD Universidad Peruana Cayetano Heredia
Principal Investigator: Witzig Richard, MD, MPH Tulane Medical School
More Information
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Responsible Party: Richard Witzig, MD, MPH, Associate Professor of Medicine., Infectious Diseases Section, Tulane School of Medicine.
ClinicalTrials.gov Identifier: NCT01277796    
Other Study ID Numbers: 032-08
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: January 17, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
 Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases