Leprosy
Conditions
Keywords
Leprosy, Ulcers, Laser
Brief summary
Neuropathic ulcers are common sequelae of leprosy. The objectives of this study are to analyze the clinic-epidemiological characteristics of patients attended at one specialized dressing service from a leprosy-endemic region of the Brazilian Amazon and to evaluate the effect of Low Level Laser Therapy on wound healing of these patients.
Interventions
PROCEDURERoutine treatment
Subjects from the Control Group received routine treatment, including daily simple dressings with sterile gauze after wound cleaning with a 0.9% physiologic solution, use of 1% hydrophilic silver sulfadiazine cream (Prati Donaduzzi Laboratory, Toledo, Brazil) and orientation about the use of adapted footwear, self-care and the prevention of disabilities. Surgical debridement was done whenever indicated by nursing or orthopedic services from UREMC.
RADIATIONLow level laser therapy (LLLT)
The LLLT equipment was an indium-gallium-aluminnium-phosphide (InGaAlP) semiconductor laser with a maximum output power of 40 mW, continuous radiation emission of visible red light with 660 nm wavelength (+/- 10 nm) and a spot area of 0.04 cm². The energy density used was 4 J per point in the wound edges and 2 J/cm² in the wound bed with a power density of 1 W/cm2. Wound beds were irradiated using a scanning technique with no direct contact.
Sponsors
Para Federal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* presented with neuropathic ulcer * attended at least 3 weekly appointments at the dressing service of UREMC * completed specific multi-drug therapy for M. leprae * gave written informed consent to participate in the study
Exclusion criteria
* clinically detectable infection in the ulcer * use of drugs, like corticosteroids that could interfere with the wound healing process * use of special dressings like hydrocolloid, calcium alginate, activated carbon or any kind of therapeutic procedure different from that used routinely for both groups of study * non-attendance to therapeutic program (six sequential times or nine intercalated) * pregnancy * discomfort during treatment procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing | Biweekly until the end of the 12 week treatment period. |
Secondary
| Measure | Time frame |
|---|---|
| Ulcer surface area, depth and PUSH tool score. | Biweekly until the end of the 12 week treatment period or until complete cicatrization of the treated ulcer. |
Countries
Brazil
Outcome results
None listed