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

Waisenmedizin e. V. Promoting Access to Essential Medicine

Status and phase: Completed; Phase 2

Conditions: Wound Healing

Treatments: Drug: Sodium Stibogluconate; Procedure: Electro-thermo-coagulation; Drug: DAC N-055

Study type: Interventional

Funder types: Other

Identifiers

NCT00996463

AFG 08/002

Details and patient eligibility

About

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.

Enrollment: 63 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 3 patient groups

IL SSG

Active Comparator group

Description:

Intralesional sodium stibogluconate

Treatment:

Drug: Sodium Stibogluconate

ETC+MWT

Experimental group

Description:

Electro-thermo-coagulation with subsequent moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)

Treatment:

Procedure: Electro-thermo-coagulation

Drug: DAC N-055

MWT

Experimental group

Description:

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

Treatment:

Drug: DAC N-055