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Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients (LEICO)

Primary Purpose

Wound Healing

Status

Completed

Phase

Phase 2

Locations

Afghanistan

Study Type

Interventional

Intervention

Electro-thermo-coagulation

Sodium Stibogluconate

DAC N-055

About this trial

This is an interventional treatment trial for Wound Healing

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Present a suspected Old World Cutaneous Leishmaniasis lesion confirmed by Giemsa stained wound smears with no other skin diseases or infections and who
Have never been previously treated with antimonial injections or any other form of anti-leishmanial medication.

Exclusion Criteria:

Patients with more than one lesion are excluded.
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.
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.
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.
For compliance reasons addicted patients and patients not available for follow-up are exclude from the trial.
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.

Sites / Locations

Leishmaniasis and Malaria Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

IL SSG

ETC+MWT

MWT

Arm Description

Intralesional sodium stibogluconate

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

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

Outcomes

Primary Outcome Measures

Wound closure time

Secondary Outcome Measures

Leishmania load parasites per gram of tissue before and after treatment

Cost-effectiveness & -utility

Full Information

NCT ID

NCT00996463

First Posted

October 15, 2009

Last Updated

March 25, 2011

Sponsor

Waisenmedizin e. V. Promoting Access to Essential Medicine

Collaborators

German Federal Ministry of Education and Research, Heidelberg University, University of Erlangen-Nürnberg Medical School

1. Study Identification

Unique Protocol Identification Number

NCT00996463

Brief Title

Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Waisenmedizin e. V. Promoting Access to Essential Medicine

Collaborators

German Federal Ministry of Education and Research, Heidelberg University, University of Erlangen-Nürnberg Medical School

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wound Healing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IL SSG

Arm Type

Active Comparator

Arm Description

Intralesional sodium stibogluconate

Arm Title

ETC+MWT

Arm Type

Experimental

Arm Description

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

Arm Title

MWT

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Electro-thermo-coagulation

Intervention Description

Electro-thermo-coagulation

Intervention Type

Drug

Intervention Name(s)

Sodium Stibogluconate

Intervention Description

Intralesional injection of sodium stibogluconate

Intervention Type

Drug

Intervention Name(s)

DAC N-055

Intervention Description

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

Primary Outcome Measure Information:

Title

Wound closure time

Time Frame

75 days

Secondary Outcome Measure Information:

Title

Leishmania load parasites per gram of tissue before and after treatment

Time Frame

75 days

Title

Cost-effectiveness & -utility

Time Frame

75 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Present a suspected Old World Cutaneous Leishmaniasis lesion confirmed by Giemsa stained wound smears with no other skin diseases or infections and who Have never been previously treated with antimonial injections or any other form of anti-leishmanial medication. Exclusion Criteria: Patients with more than one lesion are excluded. 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. 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. 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. For compliance reasons addicted patients and patients not available for follow-up are exclude from the trial. 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.

Facility Information:

Facility Name

Leishmaniasis and Malaria Center

City

Mazar-e-Sharif

State/Province

Balkh

Country

Afghanistan

12. IPD Sharing Statement

Citations:

PubMed Identifier

25420793

Citation

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.

Results Reference

derived

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Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients

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