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

This study has been completed.

Sponsor:

Collaborators:

German Federal Ministry of Education and Research

University of Heidelberg

University of Erlangen-Nürnberg Medical School

Information provided by:

Waisenmedizin e. V. Promoting Access to Essential Medicine

ClinicalTrials.gov Identifier:

NCT00996463

First received: October 15, 2009

Last updated: March 25, 2011

Last verified: October 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	October 15, 2009
Last Updated Date	March 25, 2011
Start Date ^ICMJE	January 2010
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 26, 2010)	Wound closure time [ Time Frame: 75 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: October 15, 2009)	Wound closure time
Change History	Complete list of historical versions of study NCT00996463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 26, 2010)	Leishmania load parasites per gram of tissue before and after treatment [ Time Frame: 75 days ] [ Designated as safety issue: Yes ] Cost-effectiveness & -utility [ Time Frame: 75 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: October 15, 2009)	Leishmania load parasites per gram of tissue before and after treatment Cost-effectiveness & -utility
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients
Official Title ^ICMJE	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
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: 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Wound Healing
Intervention ^ICMJE	Procedure: Electro-thermo-coagulation Electro-thermo-coagulation Drug: Sodium Stibogluconate Intralesional injection of sodium stibogluconate Drug: DAC N-055 Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
Study Arm (s)	Active Comparator: IL SSG Intralesional sodium stibogluconate Intervention: Drug: 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) Interventions: Procedure: Electro-thermo-coagulation Drug: DAC N-055 Experimental: MWT Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex) Intervention: Drug: DAC N-055
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	63
Completion Date	March 2011
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	12 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Afghanistan

Administrative Information
NCT Number ^ICMJE	NCT00996463
Other Study ID Numbers ^ICMJE	AFG 08/002
Has Data Monitoring Committee	Yes
Responsible Party	Prof. Dr. med. Dr. rer. nat. Kurt-Wilhelm Stahl, Waisenmedizin e.V. - PACEM
Study Sponsor ^ICMJE	Waisenmedizin e. V. Promoting Access to Essential Medicine
Collaborators ^ICMJE	German Federal Ministry of Education and Research University of Heidelberg University of Erlangen-Nürnberg Medical School
Investigators ^ICMJE	Not Provided
Information Provided By	Waisenmedizin e. V. Promoting Access to Essential Medicine
Verification Date	October 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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