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

Not Applicable

Completed

• Conditions: Leprosy
• Interventions: Procedure: Routine treatment; Radiation: Low level laser therapy (LLLT)

• Registration Number: NCT00860717
• Lead Sponsor: Para Federal University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2008-01
• Study Completion: 2008-04
• Status Verified: 2009-03
• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Last Update Submitted: 2009-12-12
• Last Update Posted: 2009-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Routine treatment	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.
2	Low level laser therapy (LLLT)	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.

Primary Outcome Measures

Name	Time	Method
Wound healing	Biweekly until the end of the 12 week treatment period.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dr. Marcello Candia Reference Unit in Sanitary Dermatology of the State of Pará in Brazil (UREMC); 🇧🇷 Marituba, Pará, Brazil