About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
Heat pack conduction-heat therapy
DeviceHand 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.
Treatment groups
Trial outcomes
This trial has no outcomes listed.Locations
Sponsors and contacts
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Universidad Peruana Cayetano Heredia
Lead sponsor
Tulane University School of Medicine
Collaborator