Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis (HECT)
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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.
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.
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Ages Eligible for Study:
8 Years to 80 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:
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.
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.