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Completed

NCT Number: NCT00860717

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

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.

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Key information

Conditions

Leprosy Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Mycobacterium Infections, Nontuberculous Pathologic Processes Pathological Conditions, Signs and Symptoms Ulcer

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Marcello Candia Reference Unit in Sanitary Dermatology of the State of Pará in Brazil (UREMC)

Marituba, Pará, 67200-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Routine treatment

Procedure

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.

Other names: LLLT, Cold laser, LILT

Primary outcomes

  1. Wound healing

    Time frame: Biweekly until the end of the 12 week treatment period.

Secondary outcomes

  1. Ulcer surface area, depth and PUSH tool score.

    Time frame: Biweekly until the end of the 12 week treatment period or until complete cicatrization of the treated ulcer.

Sponsors and collaborators

Lead sponsor

Para Federal University

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 12, 2009
Registry last updated
Dec 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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