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Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients (LEICO)

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ClinicalTrials.gov Identifier: NCT00996463
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : March 28, 2011
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Study Description
Brief Summary:

The rationales of a clinical trial comparing intralesional antimonial therapy versus wound care management in patients with old world cutaneous leishmaniasis (OWCL) are the following:

  1. The effectiveness of the current mainstay treatment with intralesional antimonials for CL is subject to discussion, especially in L. major lesions which are predominant in Northern Afghanistan
  2. The importance of wound care management in patients with OWCL has been emphasized by Gonzalez et al. (2008) and its efficacy is confirmed in the Kabul trial with L. tropica patients.

Parallel to the clinical efficacy the trial investigates the cost-effectiveness and -utility of the treatment options under study.

Condition or disease Intervention/treatment Phase
Wound Healing Procedure: Electro-thermo-coagulation Drug: Sodium Stibogluconate Drug: DAC N-055 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Open Randomized Clinical & Health Economic Trial Comparing Intralesional Antimony Therapy Versus Wound Care Management in Old World Cutaneous Leishmaniasis Patients in Northern Afghanistan
Study Start Date : January 2010
Primary Completion Date : September 2010
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: IL SSG
Intralesional sodium stibogluconate
Drug: Sodium Stibogluconate
Intralesional injection of sodium stibogluconate
Experimental: ETC+MWT
Electro-thermo-coagulation with subsequent moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
Procedure: Electro-thermo-coagulation
Drug: DAC N-055
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
Experimental: MWT
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
Drug: DAC N-055
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)

Outcome Measures

Primary Outcome Measures :
  1. Wound closure time [ Time Frame: 75 days ]

Secondary Outcome Measures :
  1. Leishmania load parasites per gram of tissue before and after treatment [ Time Frame: 75 days ]
  2. Cost-effectiveness & -utility [ Time Frame: 75 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Present a suspected Old World Cutaneous Leishmaniasis lesion confirmed by Giemsa stained wound smears with no other skin diseases or infections and who
  2. Have never been previously treated with antimonial injections or any other form of anti-leishmanial medication.

Exclusion Criteria:

  1. Patients with more than one lesion are excluded.
  2. Patients with a lesion age of > 3 months are also excluded. The experience of the Kabul trial shows that patients presenting themselves for the first time with a lesion, which is older than three months, have either been pre-treated somewhere else and/or show a poor compliance during the trial.
  3. Patients below 12 years of age have to be excluded from the trial, because they cannot fill in the EQ-5D and Skindex questionnaire part of the health economic evaluation.
  4. Intralesional antimony injections are too painful for lesions located on the nose, lips or eyes. Therefore, patients presenting these lesions are excluded from the trial.
  5. For compliance reasons addicted patients and patients not available for follow-up are exclude from the trial.
  6. Patients with major uncontrolled diseases as tuberculosis, diabetes or HIV are excluded from the trial, since their management requires additional co-medications, which may affect wound healing.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996463

Leishmaniasis and Malaria Center
Mazar-e-Sharif, Balkh, Afghanistan
Sponsors and Collaborators
Waisenmedizin e. V. Promoting Access to Essential Medicine
German Federal Ministry of Education and Research
Heidelberg University
University of Erlangen-Nürnberg Medical School
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. med. Dr. rer. nat. Kurt-Wilhelm Stahl, Waisenmedizin e.V. - PACEM
ClinicalTrials.gov Identifier: NCT00996463     History of Changes
Other Study ID Numbers: AFG 08/002
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: March 28, 2011
Last Verified: October 2009

Additional relevant MeSH terms:
Wounds and Injuries
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
Antiplatyhelmintic Agents