Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Intervention: Sodium stibogluconate (Pentostam); ThermoMed
Intervention description: intravenous 20 mg/kg/day for 10 days; ThermoMed heat treatment device, one treatment
Intervention MeSH terms: Antimony Sodium Gluconate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study serves to compare the effectiveness of treating cutaneous leishmaniasis with
      either intravenous sodium stibogluconate or direct heat therapy using the ThermoMed-TM
      device.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Department of Defense (DOD) Healthcare beneficiary

          -  Parasitologic diagnosis of cutaneous Leishmania infection

        (Inclusion criteria for randomization includes that must be Leishmania major species)

          -  Willing to locate to WRAMC area during treatment and perform subsequent follow-up
             visits if needed

        (If not active duty on orders, then the participant will bear the cost of food and lodging
        during the initial 10-day outpatient treatment period at Walter Reed Army Medical Center)

          -  Able to provide informed consent

          -  All participants (both male and female) must agree to take precautions not to become
             pregnant or father a child for at least 2 months after receiving sodium stibogluconate

        Exclusion Criteria:

          -  Unable to provide informed consent

          -  Pregnancy (females of child bearing potential must have negative urine human chorionic
             gonadotropic hormone [HCG] within 48 hours of the start of infusion period)

          -  History of hypersensitivity to pentavalent antimonials

          -  Serious medical illness:

               1. QTc interval >/= 0.5 sec

               2. severe cardiac disease

               3. history of current pancreatitis

               4. liver failure or active hepatitis with transaminases >3X normal

               5. renal failure or creatinine >2.5

               6. thrombocytopenia (platelets <75,000)

               7. white blood cell count <2000

               8. hematocrit <25

               9. absence of palpable extremity pulses in the limb requiring treatment

          -  History of serious allergic reaction to local anesthetics

          -  Location of lesion not amenable to local therapy (such as close to eye, mucous
             membranes, face, cartilage)

          -  Presence of pacemaker and/or other implanted metallic devices

          -  Breast feeding

          -  Men unwilling to avoid fathering a child during and/or in the two months following
             receiving the treatment

          -  Women unwilling to avoid pregnancy for at least two months after receiving the
             treatment

          -  More than 20 lesions, or multiple lesions which in the opinion of the investigator
             would not be well treated with heat therapy