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Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients

NCT00996463 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2011-03-28

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Heidelberg University

    collaborator OTHER

  • University of Erlangen-Nürnberg Medical School

    collaborator OTHER

  • Waisenmedizin e. V. Promoting Access to Essential Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-09-30
Completion
2011-03-31

Countries

  • Afghanistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00996463 on ClinicalTrials.gov