Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis

Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age8-80
SponsorUniversidad Peruana Cayetano Heredia

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 volunteers

Qualifiers

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

    Device

    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.

Treatment groups

No treatment groups listed

Trial outcomes

This trial has no outcomes listed.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Peruana Cayetano Heredia

Lead sponsor

Tulane University School of Medicine

Collaborator