Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis

NCT ID: NCT01277796

Last Updated: 2011-01-17

Basic Information

• Recruitment Status: AVAILABLE
• Study Classification: EXPANDED_ACCESS

Brief 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

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tulane University School of Medicine

OTHER

Sponsor Role: collaborator

Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role: lead

Responsible Party

Infectious Diseases Section, Tulane School of Medicine.

Principal Investigators

Alejandro Llanos-Cuentas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Peruana Cayetano Heredia

Witzig Richard, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Tulane Medical School

Central Contacts

Alejandro Llanos-Cuentas, MD, PhD

Role: CONTACT

elmer.llanos@upch.pe

51-1-482-7739

Other Identifiers

032-08

Identifier Type: -

Identifier Source: org_study_id