Status:
COMPLETED
Local Heat Therapy Versus Sodium Stibogluconate for the Treatment of Cutaneous Leishmaniasis
Lead Sponsor:
U.S. Army Medical Research and Development Command
Collaborating Sponsors:
Walter Reed Army Medical Center
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Detailed Description
A total of 56 Department of Defense health care beneficiaries, 18 years of age or older and diagnosed with cutaneous leishmaniasis, were planned to be treated with either intravenous sodium stibogluco...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00884377
Start Date
February 1 2004
End Date
March 1 2009
Last Update
January 2 2020
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307