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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Collaborator: Walter Reed Army Medical Center
• Treatments: Antimony Sodium Gluconate

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