[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100154098":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":20,"locations":7,"responsibleParty":25,"collaborators":28,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":37,"eligibilityCriteria":38,"healthyVolunteers":33,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":7,"targetDuration":7,"studyType":42,"phases":7,"briefSummary":43,"conditions":44,"keywords":7,"overallStatus":46,"whyStopped":7,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":51,"locationsCount":7},{"fullName":5,"class":6},"Universidad Peruana Cayetano Heredia","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"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.",[14,17],{"name":15,"affiliation":5,"role":16},"Alejandro Llanos-Cuentas, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":18,"affiliation":19,"role":16},"Witzig Richard, MD, MPH","Tulane Medical School",[21],{"name":15,"role":22,"phone":23,"phoneExt":7,"email":24},"CONTACT","51-1-482-7739","elmer.llanos@upch.pe",{"type":7,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":26,"oldOrganization":27},"Richard Witzig, MD, MPH, Associate Professor of Medicine.","Infectious Diseases Section, Tulane School of Medicine.",[29],{"name":30,"class":6},"Tulane University School of Medicine","100154098","pilot-study-using-a-heat-pack-to-treat-cutaneous-leishmaniasis-100154098",false,"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","HECT","Inclusion Criteria:\n\n* with CL diagnosed by skin smear (WHO method), biopsy, culture, PCR\n* aged 8-80 years old\n* with no more than 3 lesions\n* ulcerative and non-ulcerative ulcers less than 4 cm diameter.\n* allergy, prohibitive side effects to standard chemotherapy, or other contraindication to antimonial treatment (e.g. cardiac arrhythmia)\n* capable of signing an informed consent or having capable guardians (in the case of minors).\n* Children ≥ 8 years of age must give written or verbal informed assent along with written consent of their guardians.\n\nExclusion Criteria:\n\n* lesions less than 2cm from the nose, mouth, ears, or eyes.\n* clinically diagnosed with mucosal involvement.\n* evidence of lymph node involvement on exam.\n* unable or unwilling to commit to the treatment and follow-up plan.\n* prior CL treatment within last 1 month.\n* pregnant or lactating\n* uncontrolled severe systemic illness or immunocompromised state.","ALL","8 Years","80 Years","EXPANDED_ACCESS","Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are expensive, toxic\u002Fallergenic, 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.",[45],"Cutaneous Leishmaniasis","AVAILABLE","2011-01-14",{"date":49,"type":50},"2011-01-17","ESTIMATED",{"name":5,"class":6}]