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Rationale for New Topical Anthroponotic Cutaneous Leishmaniasis (ACL) Treatment in Kabul (rtt-ACL)

Primary Purpose

Wound Healing

Status
Completed
Phase
Phase 2
Locations
Afghanistan
Study Type
Interventional
Intervention
Electro-thermo-coagulation
DAC N-055
saline
Sponsored by
Waisenmedizin e. V. Promoting Access to Essential Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Healing

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

  • at least one suspected lesion positive in Giemsa smear

Exclusion Criteria:

  • patients previously treated for leishmania

Sites / Locations

  • German Medical Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ETC + DAC N-055

ETC + physiological saline

Arm Description

Outcomes

Primary Outcome Measures

Wound closure time

Secondary Outcome Measures

Leishmania load parasites per gram of tissue before and after treatment

Full Information

First Posted
July 24, 2009
Last Updated
July 27, 2009
Sponsor
Waisenmedizin e. V. Promoting Access to Essential Medicine
Collaborators
Waisenmedzin eV PACEM non-profit German NGO, German Medical Service (GMS) in Kabul, University of Freiburg, Microbiology Institute Clinical Microbiology Immunology and Hygiene University Clinic of Erlangen Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00947362
Brief Title
Rationale for New Topical Anthroponotic Cutaneous Leishmaniasis (ACL) Treatment in Kabul
Acronym
rtt-ACL
Official Title
Phase 2 Study Electrothermocauterisation of Afghan Patients With Anthroponotic Cutaneous Leishmaniasis With and Without Pharmaceutical Chlorite Listed in the German Drug Codex (DAC N-055)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Waisenmedizin e. V. Promoting Access to Essential Medicine
Collaborators
Waisenmedzin eV PACEM non-profit German NGO, German Medical Service (GMS) in Kabul, University of Freiburg, Microbiology Institute Clinical Microbiology Immunology and Hygiene University Clinic of Erlangen Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the randomized double blind trial with 134 patients presenting old world cutaneous leishmaniasis is: to evaluate the clinical efficacy of electro-thermo-cauterisation (ETC) followed by moist wound treatment versus ETC followed by moist wound treatment plus 0.05 % pharmaceutical chlorite that has been used in three European countries (Germany, Austria and Switzerland) in wound care management for more than 20 years; to judge whether early wound care management would present a viable improvement to the actual anti-parasitic treatments mostly neglecting the chronic wound problem and to evaluate its long-term effect on immunity through relapse control 6 months after wound healing.

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, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ETC + DAC N-055
Arm Type
Experimental
Arm Title
ETC + physiological saline
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Electro-thermo-coagulation
Intervention Type
Drug
Intervention Name(s)
DAC N-055
Intervention Description
moist wound treatment plus 0.05 % pharmaceutical chlorite
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
physiological saline
Primary Outcome Measure Information:
Title
Wound closure time
Secondary Outcome Measure Information:
Title
Leishmania load parasites per gram of tissue before and after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Eligibility Criteria
Inclusion Criteria: at least one suspected lesion positive in Giemsa smear Exclusion Criteria: patients previously treated for leishmania
Facility Information:
Facility Name
German Medical Service
City
Kabul
Country
Afghanistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24551257
Citation
Jebran AF, Schleicher U, Steiner R, Wentker P, Mahfuz F, Stahl HC, Amin FM, Bogdan C, Stahl KW. Rapid healing of cutaneous leishmaniasis by high-frequency electrocauterization and hydrogel wound care with or without DAC N-055: a randomized controlled phase IIa trial in Kabul. PLoS Negl Trop Dis. 2014 Feb 13;8(2):e2694. doi: 10.1371/journal.pntd.0002694. eCollection 2014 Feb.
Results Reference
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Rationale for New Topical Anthroponotic Cutaneous Leishmaniasis (ACL) Treatment in Kabul

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