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

Para Federal University

Status: Completed

Conditions: Leprosy

Treatments: Procedure: Routine treatment; Radiation: Low level laser therapy (LLLT)

Study type: Interventional

Funder types: Other

Identifiers

NCT00860717

FINEP 1460/03

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

1

Active Comparator group

Description:

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.

Treatment:

Procedure: Routine treatment

2

Experimental group

Description:

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.

Treatment:

Radiation: Low level laser therapy (LLLT)