Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis

Completed · Phase 2

Conditions studied: Cutaneous Leishmaniasis

In brief

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.

Key facts

Study ID

NCT00884377

Run by

U.S. Army Medical Research and Development Command

People needed

56

Starts

2004-02-01

Expected to finish

2009-03-01

Last updated by the study team

2020-01-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• QTc interval >/= 0.5 sec
• severe cardiac disease
• history of current pancreatitis
• liver failure or active hepatitis with transaminases >3X normal
• renal failure or creatinine >2.5
• thrombocytopenia (platelets <75,000)
• white blood cell count <2000
• hematocrit <25
• 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

Where it is running

• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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