Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis (HECT)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cutaneous Leishmaniasis |
Device: Heat pack conduction-heat therapy |
| Study Type: | Expanded Access What is Expanded Access? |
| Official Title: | Pilot Study of Thermotherapy Treatment for Cutaneous Leishmaniasis in Peru With the HECT-CL Device |
Eligibility| Ages Eligible for Study: | 8 Years to 80 Years |
| Genders Eligible for Study: | Both |
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.
Contacts and Locations| Contact: Alejandro Llanos-Cuentas, MD, PhD | 51-1-482-7739 | elmer.llanos@upch.pe |
| Principal Investigator: | Alejandro Llanos-Cuentas, MD, PhD | Universidad Peruana Cayetano Heredia |
| Principal Investigator: | Witzig Richard, MD, MPH | Tulane Medical School |
More Information
No publications provided
| Responsible Party: | Richard Witzig, MD, MPH, Associate Professor of Medicine., Infectious Diseases Section, Tulane School of Medicine. |
| ClinicalTrials.gov Identifier: | NCT01277796 History of Changes |
| Other Study ID Numbers: | 032-08 |
| Study First Received: | January 13, 2011 |
| Last Updated: | January 14, 2011 |
| Health Authority: | Peru: Ethics Committee United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Leishmaniasis Leishmaniasis, Cutaneous Euglenozoa Infections Protozoan Infections |
Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013