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Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis

NCT01277796 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2011-01-17

No results posted yet for this study

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.

Conditions

  • Cutaneous Leishmaniasis

Interventions

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.

Sponsors & Collaborators

  • Tulane University School of Medicine

    collaborator OTHER

  • Universidad Peruana Cayetano Heredia

    lead OTHER

Principal Investigators

  • Alejandro Llanos-Cuentas, MD, PhD · Universidad Peruana Cayetano Heredia

  • Witzig Richard, MD, MPH · Tulane Medical School

Eligibility

Min Age
8 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01277796 on ClinicalTrials.gov