Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients
NCT ID: NCT00996463
Last Updated: 2011-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
63 participants
INTERVENTIONAL
2010-01-31
2011-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IL SSG
Intralesional sodium stibogluconate
Sodium Stibogluconate
Intralesional injection of sodium stibogluconate
ETC+MWT
Electro-thermo-coagulation with subsequent moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
Electro-thermo-coagulation
Electro-thermo-coagulation
DAC N-055
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
MWT
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
DAC N-055
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
Interventions
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Electro-thermo-coagulation
Electro-thermo-coagulation
Sodium Stibogluconate
Intralesional injection of sodium stibogluconate
DAC N-055
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
Eligibility Criteria
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Inclusion Criteria
2. Have never been previously treated with antimonial injections or any other form of anti-leishmanial medication.
Exclusion Criteria
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.
12 Years
ALL
No
Sponsors
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German Federal Ministry of Education and Research
OTHER_GOV
Heidelberg University
OTHER
University of Erlangen-Nürnberg Medical School
OTHER
Waisenmedizin e. V. Promoting Access to Essential Medicine
OTHER
Responsible Party
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Waisenmedizin e.V. - PACEM
Locations
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Leishmaniasis and Malaria Center
Mazari Sharif, Balkh, Afghanistan
Countries
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References
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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.
Other Identifiers
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AFG 08/002
Identifier Type: -
Identifier Source: org_study_id
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