CompletedPhase 2

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

United States56 participantsStarted 2004-02

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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

What they're measuring

Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure

Timeframe: Assessment of cure is made at 2 months after treatment

Trial details

NCT IDNCT00884377

SponsorU.S. Army Medical Research and Development Command

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2009-01

Results submitted2017-02-13

View on ClinicalTrials.gov More Cutaneous Leishmaniasis trials