Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients

Study Overview
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Brief Summary
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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: 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 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.

Official Title
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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

Conditions
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Wound Healing

Intervention / Treatment
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* Procedure: Electro-thermo-coagulation
* Drug: Sodium Stibogluconate
* Drug: DAC N-055


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Present a suspected Old World Cutaneous Leishmaniasis lesion confirmed by Giemsa stained wound smears with no other skin diseases or infections and who Have never been previously treated with antimonial injections or any other form of anti-leishmanial medication. Exclusion Criteria: Patients with more than one lesion are excluded. 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. 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. 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. For compliance reasons addicted patients and patients not available for follow-up are exclude from the trial. 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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound closure time |  | 75 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leishmania load parasites per gram of tissue before and after treatment |  | 75 days | 
| Cost-effectiveness & -utility |  | 75 days |