Wound Healing
Conditions
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.
Interventions
PROCEDUREElectro-thermo-coagulation
Electro-thermo-coagulation
Intralesional injection of sodium stibogluconate
DRUGDAC N-055
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
Sponsors
German Federal Ministry of Education and Research
Heidelberg University
University of Erlangen-Nürnberg Medical School
Waisenmedizin e. V. Promoting Access to Essential Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound closure time | 75 days |
Secondary
| Measure | Time frame |
|---|---|
| Leishmania load parasites per gram of tissue before and after treatment | 75 days |
| Cost-effectiveness & -utility | 75 days |
Countries
Afghanistan
Outcome results
None listed