The Use of Low Level Laser Therapy for Wound Healing in Leprosy Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Leprosy

Intervention / Treatment
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* Procedure: Routine treatment
* Radiation: Low level laser therapy (LLLT)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Subjects from the arm number 1 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. | Procedure: Routine treatment<br>* 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.<br>|
| Experimental: 2<br>Subjects from the arm number 2 received low level laser therapy 3 times per week for 12 weeks, in addition to the same treatment as patients from the arm number 1. | Radiation: Low level laser therapy (LLLT)<br>* 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.<br>* Other names: LILT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing |  | Biweekly until the end of the 12 week treatment period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leprosy, Ulcers, Laser