Wound Healing
Conditions
Brief 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 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.
Interventions
DRUGDAC N-055
moist wound treatment plus 0.05 % pharmaceutical chlorite
DRUGsaline
physiological saline
Sponsors
German Medical Service (GMS) in Kabul
University of Freiburg
Waisenmedizin e. V. Promoting Access to Essential Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* at least one suspected lesion positive in Giemsa smear
Exclusion criteria
* patients previously treated for leishmania
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days for wound closure | From the day of treatment start to the day of wound closure | Days for primary wound closure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leishmania parasites load per gram of tissue before and after treatment | Before treatment start and at day wound closure | Parasite load per gram of tissue |
Countries
Afghanistan
Outcome results
None listed