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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
| Heidelberg University | OTHER |
| University of Erlangen-Nürnberg Medical School | OTHER |
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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:
Parallel to the clinical efficacy the trial investigates the cost-effectiveness and -utility of the treatment options under study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IL SSG | Active Comparator | Intralesional sodium stibogluconate |
|
| ETC+MWT | Experimental | Electro-thermo-coagulation with subsequent moist wound treatment with DAC N-055 (German officinal drug of the German drug codex) |
|
| MWT | Experimental | Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electro-thermo-coagulation | Procedure | Electro-thermo-coagulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wound closure time | 75 days |
| Measure | Description | Time Frame |
|---|---|---|
| Leishmania load parasites per gram of tissue before and after treatment | 75 days | |
| Cost-effectiveness & -utility | 75 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leishmaniasis and Malaria Center | Mazari Sharif | Balkh | Afghanistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25420793 | Derived | Stahl HC, Ahmadi F, Schleicher U, Sauerborn R, Bermejo JL, Amirih ML, Sakhayee I, Bogdan C, Stahl KW. A randomized controlled phase IIb wound healing trial of cutaneous leishmaniasis ulcers with 0.045% pharmaceutical chlorite (DAC N-055) with and without bipolar high frequency electro-cauterization versus intralesional antimony in Afghanistan. BMC Infect Dis. 2014 Nov 25;14:619. doi: 10.1186/s12879-014-0619-8. |
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| ID | Term |
|---|---|
| D000967 | Antimony Sodium Gluconate |
| ID | Term |
|---|---|
| D009930 | Organic Chemicals |
| D005942 | Gluconates |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
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| Sodium Stibogluconate |
| Drug |
Intralesional injection of sodium stibogluconate |
|
| DAC N-055 | Drug | Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex) |
|
| D002264 |
| Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |