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

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00884377
First received: April 17, 2009
Last updated: June 15, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Cutaneous Leishmaniasis Drug: Sodium stibogluconate (Pentostam) Device: ThermoMed Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase I/II Randomized Comparison of Localized Heat Therapy Versus Sodium Stibogluconate (Pentostam) for the Treatment of Old World Cutaneous Leishmaniasis (HSRRB Log No. A-12364)

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • Equivalence of Efficacy Assessed by the Number of Participants With Clinical Cure [ Time Frame: Assessment of cure is made at 2 months after treatment ]
    Assess whether local heat therapy using the ThermoMed device was equivalent (clinical cure) in efficacy to 10 days of parenteral sodium stibogluconate. Clinical cure is defined as complete epithelialization of lesion. post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.


Secondary Outcome Measures:
  • Equivalence of Efficacy (Clinical Cure) of TheroMed Treatment vs Sodium Stibogluconate Assessed by the Number of Subjects With Clinical Cure [ Time Frame: 12 months ]
    Determine the equivalence of efficacy (clinical cure) of ThermoMed treatment vs sodium stibogluconate in clinical response of all skin lesions at 12 months. Clinical cure is defined as complete epithelialization of lesion. Post-treatment, photographs of treated lesions were assessed for efficacy outcome by a consensus decision of leishmaniasis experts blinded as to each subject's study group. On the basis of these photo assessments, "clinical response" was assessed by lesion and by subject. In addition, an "overall response" was assigned ("healed" or "not healed") based on a combination of experts' photo assessments and subject interviews. Efficacy outcomes for the 2 study groups were compared using the Fishers exact test.

  • Number of Participants With Solicited Adverse Events [ Time Frame: Days 3, 7 and 10 ]
    To compare the toxicity profiles of ThermoMed treatment versus parenteral sodium stibogluconate therapy thru specific solicited adverse events

  • Immune Response, Based on T-Cell Population Before Treatment, and Day 10 Following Treatments [ Time Frame: day 1 and day 10 ]
    Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.

  • Immune Response, Based on Percent of T-Cell Population Before Treatment, and Day 10 Following Treatments [ Time Frame: day 1 and day 10 ]
    Evaluate the immune response (T-Cell population) to Leishmania before treatment, and at 10 days, in recipients of localized heat therapy vs systemic sodium stibogluconate. Days 1 and 10 are presented in columns.

  • Feasibility of a L. Major Species Specific Polymerase Chain Reaction as a Rapid Diagnostic Device in the Context of a Treatment Trial [ Time Frame: at baseline before treatment ]
    Evaluate the feasibility of using species-specific PCR as a rapid diagnostic assay for L. major infection. The comparator modalities were: histopathology (identification of amastigotes); speciation determined through culture and isoenzyme analysis; and genus and species-specific PCR. Species PCR testing was performed at baseline to allow for the identification of L. major as each subject's infecting parasite. If an L. major infection could not be confirmed in a subject's lesion(s), then that subject could not be treated under this protocol.


Enrollment: 56
Study Start Date: February 2004
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sodium stibogluconate intravenous
20 mg/kg/day Sodium stibogluconate intravenous
Drug: Sodium stibogluconate (Pentostam)
intravenous 20 mg/kg/day for 10 days
Other Names:
  • Pentostam
  • WR 229,870
Experimental: ThermoMed device
ThermoMed device, single heat treatment at 50 degrees Celsius
Device: ThermoMed
ThermoMed heat treatment device, one treatment

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 stibogluconate (Pentostam-TM) or the ThermoMed-TM device of Thermosurgery Technologies, Inc. at the Walter Reed Army Medical Center. Pentostam is the standard of care for this disease, but the i.v. administration and the many known side effects prompt the search for an improved method of treating this disease, especially for milder cases. This study compares the safety and efficacy of these two treatment approached.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884377

Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington, D.C., District of Columbia, United States, 20307
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Walter Reed Army Medical Center
Investigators
Principal Investigator: COL Naomi Aronson, M.D. Uniformed Services University of the Health Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00884377     History of Changes
Other Study ID Numbers: A-12364
Study First Received: April 17, 2009
Results First Received: February 13, 2017
Last Updated: June 15, 2017

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antimony Sodium Gluconate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on August 16, 2017