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

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ClinicalTrials.gov Identifier: NCT00860717
Recruitment Status : Completed
First Posted : March 12, 2009
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Leprosy Procedure: Routine treatment Radiation: Low level laser therapy (LLLT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinic-Epidemiological Evaluation of Ulcers in Leprosy Patients and the Use of Low Level Laser Therapy: a Randomized Clinical Trial
Study Start Date : November 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : April 2008

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Arm Intervention/treatment
Active Comparator: 1
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
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.

Experimental: 2
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)

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 Outcome Measures :
  1. Wound healing [ Time Frame: Biweekly until the end of the 12 week treatment period. ]

Secondary Outcome Measures :
  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. ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860717


Locations
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Brazil
Dr. Marcello Candia Reference Unit in Sanitary Dermatology of the State of Pará in Brazil (UREMC)
Marituba, Pará, Brazil, 67200-000
Sponsors and Collaborators
Para Federal University
Investigators
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Study Director: Claudio G Salgado, Dr Federal University of Pará

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Claudio Guedes Salgado, Federal University of Pará
ClinicalTrials.gov Identifier: NCT00860717     History of Changes
Other Study ID Numbers: FINEP 1460/03
First Posted: March 12, 2009    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: March 2009
Keywords provided by Para Federal University:
Leprosy
Ulcers
Laser
Additional relevant MeSH terms:
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Leprosy
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Silver Sulfadiazine
Anti-Infective Agents
Anti-Infective Agents, Local