Wound HealingPhase 2/3rtt-ACLNCT00947362
Rationale for New Topical Anthroponotic Cutaneous Leishmaniasis (ACL) Treatment in Kabul
A Phase 2/3 study testing Electro-thermo-coagulation, DAC N-055 and saline in people with Wound Healing, run by Waisenmedizin e. V. Promoting Access to Essential Medicine at 1 site in Afghanistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 99 years
- Conditions the study is for
- Wound Healing
- What is being tested?
- Electro-thermo-coagulation, DAC N-055 and saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteAfghanistan
- Study dates
- 1 Aug 2004to 15 Dec 2007
- Phase
- Phase 2/3
- 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 5 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- at least one suspected lesion positive in Giemsa smear
Who cannot join
- patients previously treated for leishmania
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Wound Healing
- Being tested
- Electro-thermo-coagulation, DAC N-055, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-thermo-coagulationOther
DAC N-055Drug
moist wound treatment plus 0.05 % pharmaceutical chlorite
salineDrug
physiological saline
| Study group | Role | What they receive |
|---|---|---|
| ETC + DAC N-055 | Experimental | Not described Receives: Other: Electro-thermo-coagulation; Drug: DAC N-055 |
| ETC + physiological saline | Active comparator | Not described Receives: Other: Electro-thermo-coagulation; Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days for wound closure
Days for primary wound closure
Measured: From the day of treatment start to the day of "wound closure"
Secondary outcomes (1)
Leishmania parasites load per gram of tissue before and after treatment
Parasite load per gram of tissue
Measured: Before treatment start and at day "wound closure"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study start1 Aug 2004
- Primary completion15 Dec 2007
- Study completion15 Dec 2007
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Waisenmedizin e. V. Promoting Access to Essential Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- German Medical Service (GMS) in Kabul, University of Freiburg
- Responsible party
- Principal investigator, Kurt-Wilhelm Stahl, Waisenmedizin e. V. Promoting Access to Essential Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947362
- Sponsor's protocol ID
- 169/04
- Other IDs
- No grant or contract number
- Acronym
- rtt-ACL
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2009
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24551257
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00947362
- Acronym / sponsor ID
- rtt-ACL / 169/04
- Conditions
- Wound Healing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Waisenmedizin e. V. Promoting Access to Essential MedicineUniversity, hospital or other
- Collaborators
- German Medical Service (GMS) in Kabul, University of Freiburg
- Study start
- 1 Aug 2004 (actual)
- Primary completion
- 15 Dec 2007 (actual)
- Study completion
- 15 Dec 2007 (actual)
- First posted
- 28 Jul 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETC + DAC N-055 | Experimental | Other: Electro-thermo-coagulation, Drug: DAC N-055 |
| ETC + physiological saline | Active comparator | Other: Electro-thermo-coagulation, Drug: saline |
Who may qualify
- Ages
- 5 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- at least one suspected lesion positive in Giemsa smear
Key exclusion criteria (1 listed)
- patients previously treated for leishmania
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-coagulation | Other | ETC + DAC N-055, ETC + physiological saline |
| DAC N-055moist wound treatment plus 0.05 % pharmaceutical chlorite | Drug | ETC + DAC N-055 |
| salinephysiological saline | Drug | ETC + physiological saline |
Primary outcome
Days for wound closure
Time frame: From the day of treatment start to the day of "wound closure"
Days for primary wound closure
1 secondary outcome
Leishmania parasites load per gram of tissue before and after treatment
Time frame: Before treatment start and at day "wound closure"
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 8 Aug 2025.
- Derived from this study: PubMed 24551257Jebran 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.
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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 2/3 study testing Electro-thermo-coagulation, DAC N-055 and saline 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 1 inclusion and 1 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 8 Aug 2025. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Days for wound closure (time frame: From the day of treatment start to the day of "wound closure"). 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 NCT00947362, 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 8 Aug 2025.