Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients

Phase 2

Completed

• Conditions: Wound Healing
• Interventions: Drug: Sodium Stibogluconate; Procedure: Electro-thermo-coagulation; Drug: DAC N-055

• Registration Number: NCT00996463
• Lead Sponsor: Waisenmedizin e. V. Promoting Access to Essential Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-10
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Study Start: 2010-01
• Primary Completion: 2010-09
• Study Completion: 2011-03
• Last Update Submitted: 2011-03-25
• Last Update Posted: 2011-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IL SSG	Sodium Stibogluconate	Intralesional sodium stibogluconate
ETC+MWT	Electro-thermo-coagulation	Electro-thermo-coagulation with subsequent moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
ETC+MWT	DAC N-055	Electro-thermo-coagulation with subsequent moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
MWT	DAC N-055	Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)

Primary Outcome Measures

Name	Time	Method
Wound closure time	75 days

Secondary Outcome Measures

Name	Time	Method
Leishmania load parasites per gram of tissue before and after treatment	75 days
Cost-effectiveness & -utility	75 days

Trial Locations

Locations (1)

Leishmaniasis and Malaria Center; 🇦🇫 Mazar-e-Sharif, Balkh, Afghanistan