Skip to main content
OpenTrials
Completed

NCT Number: NCT00996463

Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Leishmaniasis and Malaria Center

Mazari Sharif, Balkh, Afghanistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electro-thermo-coagulation

Procedure

Electro-thermo-coagulation

sodium stibogluconate

Drug

Intralesional injection of sodium stibogluconate

DAC N-055

Drug

Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)

Primary outcomes

  1. Wound closure time

    Time frame: 75 days

Secondary outcomes

  1. Leishmania load parasites per gram of tissue before and after treatment

    Time frame: 75 days

  2. Cost-effectiveness & -utility

    Time frame: 75 days

Sponsors and collaborators

Lead sponsor

Waisenmedizin e. V. Promoting Access to Essential Medicine

Other

Collaborators

  • German Federal Ministry of Education and Research
  • Heidelberg University
  • University of Erlangen-Nürnberg Medical School

Registry information

Official study 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

Acronym: LEICO

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Oct 16, 2009
Registry last updated
Mar 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.