Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients (LEICO)
This study has been completed.
Sponsor:
Waisenmedizin e. V. Promoting Access to Essential Medicine
Collaborators:
German Federal Ministry of Education and Research
University of Heidelberg
University of Erlangen-Nürnberg Medical School
Information provided by:
Waisenmedizin e. V. Promoting Access to Essential Medicine
ClinicalTrials.gov Identifier:
NCT00996463
First received: October 15, 2009
Last updated: March 25, 2011
Last verified: October 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Wound Healing |
Procedure: Electro-thermo-coagulation Drug: Sodium Stibogluconate Drug: DAC N-055 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Waisenmedizin e. V. Promoting Access to Essential Medicine:
Primary Outcome Measures:
- Wound closure time [ Time Frame: 75 days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Leishmania load parasites per gram of tissue before and after treatment [ Time Frame: 75 days ] [ Designated as safety issue: Yes ]
- Cost-effectiveness & -utility [ Time Frame: 75 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 63 |
| Study Start Date: | January 2010 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: IL SSG
Intralesional sodium stibogluconate
|
Drug: Sodium Stibogluconate
Intralesional injection of sodium stibogluconate
|
|
Experimental: ETC+MWT
Electro-thermo-coagulation with subsequent moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
|
Procedure: Electro-thermo-coagulation
Electro-thermo-coagulation
Drug: DAC N-055
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
|
|
Experimental: MWT
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
|
Drug: DAC N-055
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00996463
Locations
| Afghanistan | |
| Leishmaniasis and Malaria Center | |
| Mazar-e-Sharif, Balkh, Afghanistan | |
Sponsors and Collaborators
Waisenmedizin e. V. Promoting Access to Essential Medicine
German Federal Ministry of Education and Research
University of Heidelberg
University of Erlangen-Nürnberg Medical School
More Information
No publications provided
| Responsible Party: | Prof. Dr. med. Dr. rer. nat. Kurt-Wilhelm Stahl, Waisenmedizin e.V. - PACEM |
| ClinicalTrials.gov Identifier: | NCT00996463 History of Changes |
| Other Study ID Numbers: | AFG 08/002 |
| Study First Received: | October 15, 2009 |
| Last Updated: | March 25, 2011 |
| Health Authority: | Afghanistan: Research Directorate, Ministry of Public Health |
Additional relevant MeSH terms:
|
Leishmaniasis Leishmaniasis, Cutaneous Euglenozoa Infections Protozoan Infections Parasitic Diseases Skin Diseases, Parasitic Skin Diseases, Infectious Skin Diseases Antimony Sodium Gluconate |
Schistosomicides Antiplatyhelmintic Agents Anthelmintics Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents |
ClinicalTrials.gov processed this record on May 16, 2013