NCT01277796

Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis

Pilot Study of Thermotherapy Treatment for Cutaneous Leishmaniasis in Peru With the HECT-CL Device

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Universidad Peruana Cayetano Heredia · Academic / Other
• Sex: All
• Age: 8 Years – 80 Years
• Healthy volunteers: —

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

Type	Name	Description
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.

Timeline

• First posted: 2011-01-17
• Last updated: 2011-01-17