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

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.
 
ClinicalTrials.gov Identifier: NCT00996463
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : March 28, 2011
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE October 15, 2009
First Posted Date  ICMJE October 16, 2009
Last Update Posted Date March 28, 2011
Study Start Date  ICMJE January 2010
Actual 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2009)
Wound closure time
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2010)
  • Leishmania load parasites per gram of tissue before and after treatment [ Time Frame: 75 days ]
  • Cost-effectiveness & -utility [ Time Frame: 75 days ]
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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:

  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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Arms  ICMJE
  • 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 * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 15, 2009)
63
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Afghanistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00996463
Other Study ID Numbers  ICMJE AFG 08/002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
  • Heidelberg University
  • University of Erlangen-Nürnberg Medical School
Investigators  ICMJE Not Provided
PRS Account 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