Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis

Cutaneous Leishmaniasis Clinical Trial

— HECT  

Official title:

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

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT01277796
• Other study ID #: 032-08
• Status: Available
• Phase: N/A
• First received: January 13, 2011
• Last updated: January 14, 2011

Study information

• Verified date: January 2011
• Source: Universidad Peruana Cayetano Heredia
• Contact: Alejandro Llanos-Cuentas, MD, PhD
• Phone: 51-1-482-7739
• Email: elmer.llanos[@]upch.pe
• Is FDA regulated: No
• Health authority: Peru: Ethics CommitteeUnited States: Institutional Review Board
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: Both
• Age group: 8 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

N/A

Related Conditions & MeSH terms

• Cutaneous Leishmaniasis
• Leishmaniasis
• Leishmaniasis, Cutaneous

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Peruana Cayetano Heredia	Tulane University School of Medicine