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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
January 13, 2011
January 17, 2011
January 17, 2011
 
Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis
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.
Not Provided
Expanded Access
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.
Not Provided
 
Available
Contact: Alejandro Llanos-Cuentas, MD, PhD 51-1-482-7739 elmer.llanos@upch.pe
Not Provided
 
 
NCT01277796
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