CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Routine treatment +1 moreprocedure
Likely dose
Not stated in record
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Search/NCT00860717
NCT00860717N/ACompleted

Clinic-Epidemiological Evaluation of Ulcers in Leprosy Patients and the Use of Low Level Laser Therapy: a Randomized Clinical Trial

Para Federal University·interventional·Posted Mar 12, 2009·Updated Dec 15, 2009

In Brief

A clinical study evaluating Routine treatment and Low level laser therapy (LLLT) for Leprosy. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeprosy
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 12, 2009
Enrollment StartNov 1, 2006
Primary CompletionJan 1, 2008
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.3 years ago

Interventions

Routine treatmentprocedure

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.

Low level laser therapy (LLLT)radiation

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.