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

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

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.

Study Overview

• Status: Completed
• Conditions: Wound Healing
• Intervention / Treatment: Drug: Sodium Stibogluconate; Procedure: Electro-thermo-coagulation; Drug: DAC N-055

• Study Type: Interventional
• Enrollment (Anticipated): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Wound closure time	75 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Leishmania load parasites per gram of tissue before and after treatment	75 days
Cost-effectiveness & -utility	75 days

Collaborators and Investigators

• Sponsor: Waisenmedizin e. V. Promoting Access to Essential Medicine
• Collaborators: University of Erlangen-Nürnberg Medical School; German Federal Ministry of Education and Research; Heidelberg University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: October 15, 2009
• First Submitted That Met QC Criteria: October 15, 2009
• First Posted (Estimate): October 16, 2009

Study Record Updates

• Last Update Posted (Estimate): March 28, 2011
• Last Update Submitted That Met QC Criteria: March 25, 2011
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Euglenozoa Infections; Wounds and Injuries; Leishmaniasis; Leishmaniasis, Cutaneous; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Anthelmintics; Schistosomicides; Antiplatyhelmintic Agents; Antimony Sodium Gluconate
• Other Study ID Numbers: AFG 08/002