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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00996463
First Posted: October 16, 2009
Last Update Posted: March 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
German Federal Ministry of Education and Research
Heidelberg University
University of Erlangen-Nürnberg Medical School
Information provided by:
Waisenmedizin e. V. Promoting Access to Essential Medicine
October 15, 2009
October 16, 2009
March 28, 2011
January 2010
September 2010   (Final data collection date for primary outcome measure)
Wound closure time [ Time Frame: 75 days ]
Wound closure time
Complete list of historical versions of study NCT00996463 on ClinicalTrials.gov Archive Site
  • Leishmania load parasites per gram of tissue before and after treatment [ Time Frame: 75 days ]
  • Cost-effectiveness & -utility [ Time Frame: 75 days ]
  • Leishmania load parasites per gram of tissue before and after treatment
  • Cost-effectiveness & -utility
Not Provided
Not Provided
 
Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Wound Healing
  • 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)
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
March 2011
September 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Afghanistan
 
 
NCT00996463
AFG 08/002
Yes
Not Provided
Not Provided
Prof. Dr. med. Dr. rer. nat. Kurt-Wilhelm Stahl, Waisenmedizin e.V. - PACEM
Waisenmedizin e. V. Promoting Access to Essential Medicine
  • German Federal Ministry of Education and Research
  • Heidelberg University
  • University of Erlangen-Nürnberg Medical School
Not Provided
Waisenmedizin e. V. Promoting Access to Essential Medicine
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP