NCT00996463

Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Waisenmedizin e. V. Promoting Access to Essential Medicine · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wound Healing

Interventions

Type	Name	Description
PROCEDURE	Electro-thermo-coagulation	Electro-thermo-coagulation
DRUG	Sodium Stibogluconate	Intralesional injection of sodium stibogluconate
DRUG	DAC N-055	Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-09-01
• Completion: 2011-03-01
• First posted: 2009-10-16
• Last updated: 2011-03-28

Locations

1 site across 1 country: Afghanistan