Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients

Wound Healing Clinical Trial

— LEICO  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996463
• Other study ID #: AFG 08/002
• Status: Completed
• Phase: Phase 2
• First received: October 15, 2009
• Last updated: March 25, 2011
• Start date: January 2010
• Est. completion date: March 2011

Study information

• Verified date: October 2009
• Source: Waisenmedizin e. V. Promoting Access to Essential Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Afghanistan: Research Directorate, Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leishmaniasis
• Leishmaniasis, Cutaneous
• Wound Healing

Intervention

Procedure:
• Electro-thermo-coagulation
Electro-thermo-coagulation

Drug:
• Sodium Stibogluconate
Intralesional injection of sodium stibogluconate
• DAC N-055
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)

Locations

Country	Name	City	State
Afghanistan	Leishmaniasis and Malaria Center	Mazar-e-Sharif	Balkh

Sponsors (4)

Lead Sponsor	Collaborator
Waisenmedizin e. V. Promoting Access to Essential Medicine	German Federal Ministry of Education and Research, Heidelberg University, University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Afghanistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound closure time		75 days	Yes
Secondary	Leishmania load parasites per gram of tissue before and after treatment		75 days	Yes
Secondary	Cost-effectiveness & -utility		75 days	No