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CompletedNCT00996463LEICOUpdated Mar 28, 2011

Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients

A Phase 2 interventional study of Electro-thermo-coagulation and Sodium Stibogluconate in Wound Healing, sponsored by Waisenmedizin e. V. Promoting Access to Essential Medicine. Completed at 1 site in Afghanistan. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2011-03-28.

Sponsored by Waisenmedizin e. V. Promoting Access to Essential Medicine · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

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.

02

Conditions studied

  • Wound Healing
03

In context

Lead sponsor

Waisenmedizin e. V. Promoting Access to Essential Medicine is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 are excluded from the trial, since their management requires additional co-medications, which may affect wound healing.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
63 participants (estimated)

Study arms

  • Active comparator
    IL SSG

    Intralesional sodium stibogluconate

    Drug: 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 · Drug: DAC N-055

  • Experimental
    MWT

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

    Drug: DAC N-055

Interventions

  • ProcedureElectro-thermo-coagulation

    Electro-thermo-coagulation

  • DrugSodium Stibogluconate

    Intralesional injection of sodium stibogluconate

  • DrugDAC N-055

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

06

What researchers measure

Primary outcomes

  1. Wound closure time

    Time frame: 75 days

Secondary outcomes

  1. Leishmania load parasites per gram of tissue before and after treatment

    Time frame: 75 days

  2. Cost-effectiveness & -utility

    Time frame: 75 days

07

Study locations

1 site
  • Leishmaniasis and Malaria Center
    Mazar-e-Sharif, Balkh, Afghanistan
08

References and documents

Publications

  • 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. PubMed 25420793 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00996463
Lead 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
First posted
Oct 16, 2009
Start date
Jan 2010
Primary completion
Sep 2010
Completion
Mar 2011
Last update
Mar 28, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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