Wound HealingPhase 2LEICONCT00996463
Rationales for Wound Care Management in Old World Cutaneous Leishmaniasis Patients
A Phase 2 study testing Electro-thermo-coagulation, Sodium Stibogluconate and DAC N-055 in people with Wound Healing, run by Waisenmedizin e. V. Promoting Access to Essential Medicine at 1 site in Afghanistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Wound Healing
- What is being tested?
- Electro-thermo-coagulation, Sodium Stibogluconate and DAC N-055
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteAfghanistan
- Study dates
- Jan 2010to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Wound Healing
- Being tested
- Electro-thermo-coagulation, Sodium Stibogluconate, DAC N-055
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-thermo-coagulationProcedure or surgery
Electro-thermo-coagulation
Sodium StibogluconateDrug
Intralesional injection of sodium stibogluconate
DAC N-055Drug
Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex)
| Study group | Role | What they receive |
|---|---|---|
| IL SSG | Active comparator | Intralesional sodium stibogluconate Receives: Drug: Sodium Stibogluconate |
| ETC+MWT | Experimental | Electro-thermo-coagulation with subsequent moist wound treatment with DAC N-055 (German officinal drug of the German drug codex) Receives: Procedure: Electro-thermo-coagulation; Drug: DAC N-055 |
| MWT | Experimental | Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex) Receives: Drug: DAC N-055 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound closure time
Measured: 75 days
Secondary outcomes (2)
Leishmania load parasites per gram of tissue before and after treatment
Measured: 75 days
Cost-effectiveness & -utility
Measured: 75 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waisenmedizin e. V. Promoting Access to Essential Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Heidelberg University, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996463
- Sponsor's protocol ID
- AFG 08/002
- Acronym
- LEICO
- Status last verified
- Oct 2009
- First submitted
- 15 Oct 2009
- Last updated
- 28 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00996463
- Acronym / sponsor ID
- LEICO / AFG 08/002
- Conditions
- Wound Healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Waisenmedizin e. V. Promoting Access to Essential MedicineUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Heidelberg University, University of Erlangen-Nürnberg Medical School
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 16 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IL SSG | Active comparator | Drug: Sodium StibogluconateIntralesional sodium stibogluconate |
| ETC+MWT | Experimental | Procedure: Electro-thermo-coagulation, Drug: DAC N-055Electro-thermo-coagulation with subsequent moist wound treatment with DAC N-055 (German officinal drug of the German drug codex) |
| MWT | Experimental | Drug: DAC N-055Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electro-thermo-coagulationElectro-thermo-coagulation | Procedure or surgery | ETC+MWT |
| Sodium StibogluconateIntralesional injection of sodium stibogluconate | Drug | IL SSG |
| DAC N-055Moist wound treatment with DAC N-055 (German officinal drug of the German drug codex) | Drug | ETC+MWT, MWT |
Primary outcome
Wound closure time
Time frame: 75 days
2 secondary outcomes
Leishmania load parasites per gram of tissue before and after treatment
Time frame: 75 days
Cost-effectiveness & -utility
Time frame: 75 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2011.
- Derived from this study: PubMed 25420793Stahl 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Electro-thermo-coagulation, Sodium Stibogluconate and DAC N-055 in people with Wound Healing, run by Waisenmedizin e. V. Promoting Access to Essential Medicine at 1 site in Afghanistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Afghanistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound closure time (time frame: 75 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00996463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2011.