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

Expanded access is currently available for this treatment.
Verified January 2011 by Universidad Peruana Cayetano Heredia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01277796
First Posted: January 17, 2011
Last Update Posted: January 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Tulane University School of Medicine
Information provided by:
Universidad Peruana Cayetano Heredia
  Purpose
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 Intervention
Cutaneous Leishmaniasis Device: Heat pack conduction-heat therapy

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

Resource links provided by NLM:


Further study details as provided by Universidad Peruana Cayetano Heredia:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 80 Years   (Child, Adult, Senior)
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
Information from the National Library of Medicine

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
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
Principal Investigator: Alejandro Llanos-Cuentas, MD, PhD Universidad Peruana Cayetano Heredia
Principal Investigator: Witzig Richard, MD, MPH Tulane Medical School
  More Information

Responsible Party: Richard Witzig, MD, MPH, Associate Professor of Medicine., Infectious Diseases Section, Tulane School of Medicine.
ClinicalTrials.gov Identifier: NCT01277796     History of Changes
Other Study ID Numbers: 032-08
First Submitted: January 13, 2011
First Posted: January 17, 2011
Last Update Posted: January 17, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases