Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients

NCT ID: NCT00996463

Last Updated: 2011-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-03-31

Brief Summary

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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

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Conditions

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Wound Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IL SSG

Intralesional sodium stibogluconate

Group Type ACTIVE_COMPARATOR

Sodium Stibogluconate

Intervention Type DRUG

Intralesional injection of sodium stibogluconate

ETC+MWT

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

Group Type EXPERIMENTAL

Electro-thermo-coagulation

Intervention Type PROCEDURE

Electro-thermo-coagulation

DAC N-055

Intervention Type DRUG

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

MWT

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

Group Type EXPERIMENTAL

DAC N-055

Intervention Type DRUG

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

Interventions

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Electro-thermo-coagulation

Electro-thermo-coagulation

Intervention Type PROCEDURE

Sodium Stibogluconate

Intralesional injection of sodium stibogluconate

Intervention Type DRUG

DAC N-055

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

Heidelberg University

OTHER

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role collaborator

Waisenmedizin e. V. Promoting Access to Essential Medicine

OTHER

Sponsor Role lead

Responsible Party

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Waisenmedizin e.V. - PACEM

Locations

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Leishmaniasis and Malaria Center

Mazari Sharif, Balkh, Afghanistan

Site Status

Countries

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Afghanistan

References

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Stahl HC, Ahmadi F, Schleicher U, Sauerborn R, Bermejo JL, Amirih ML, Sakhayee I, Bogdan C, Stahl KW. A randomized controlled phase IIb wound healing trial of cutaneous leishmaniasis ulcers with 0.045% pharmaceutical chlorite (DAC N-055) with and without bipolar high frequency electro-cauterization versus intralesional antimony in Afghanistan. BMC Infect Dis. 2014 Nov 25;14:619. doi: 10.1186/s12879-014-0619-8.

Reference Type DERIVED
PMID: 25420793 (View on PubMed)

Other Identifiers

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AFG 08/002

Identifier Type: -

Identifier Source: org_study_id

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