Status:
COMPLETED
Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients
Lead Sponsor:
Waisenmedizin e. V. Promoting Access to Essential Medicine
Collaborating Sponsors:
German Federal Ministry of Education and Research
Heidelberg University
Conditions:
Wound Healing
Eligibility:
All Genders
12+ years
Phase:
PHASE2
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 effectiv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00996463
Start Date
January 1 2010
End Date
March 1 2011
Last Update
March 28 2011
Active Locations (1)
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1
Leishmaniasis and Malaria Center
Mazari Sharif, Balkh, Afghanistan