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
Heidelberg University
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
  Purpose

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.


Condition Intervention Phase
Wound Healing
Procedure: Electro-thermo-coagulation
Drug: Sodium Stibogluconate
Drug: DAC N-055
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Waisenmedizin e. V. Promoting Access to Essential Medicine:

Primary Outcome Measures:
  • Wound closure time [ Time Frame: 75 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 63
Study Start Date: January 2010
Study Completion Date: March 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IL SSG
Intralesional sodium stibogluconate
Drug: Sodium Stibogluconate
Intralesional injection of 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)
Procedure: Electro-thermo-coagulation
Electro-thermo-coagulation
Drug: DAC N-055
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
Experimental: MWT
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
Drug: DAC N-055
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996463

Locations
Afghanistan
Leishmaniasis and Malaria Center
Mazar-e-Sharif, Balkh, Afghanistan
Sponsors and Collaborators
Waisenmedizin e. V. Promoting Access to Essential Medicine
German Federal Ministry of Education and Research
Heidelberg University
University of Erlangen-Nürnberg Medical School
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Dr. rer. nat. Kurt-Wilhelm Stahl, Waisenmedizin e.V. - PACEM
ClinicalTrials.gov Identifier: NCT00996463     History of Changes
Other Study ID Numbers: AFG 08/002
Study First Received: October 15, 2009
Last Updated: March 25, 2011
Health Authority: Afghanistan: Research Directorate, Ministry of Public Health

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Cutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antimony Sodium Gluconate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on August 28, 2014