The Use of Low Level Laser Therapy for Wound Healing in Leprosy Patients - Full Text View

Sponsored by:	Para Federal University
Information provided by:	Para Federal University
ClinicalTrials.gov Identifier:	NCT00860717

Purpose

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	Intervention
Leprosy	Procedure: Routine treatment Radiation: Low level laser therapy (LLLT)

MedlinePlus related topics: Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Clinic-Epidemiological Evaluation of Ulcers in Leprosy Patients and the Use of Low Level Laser Therapy: a Randomized Clinical Trial

Further study details as provided by Para Federal University:

Primary Outcome Measures:

Wound healing [ Time Frame: Bimonthly until the end of the 12 week treatment period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Ulcer surface area, depth and PUSH tool score. [ Time Frame: Bimonthly until the end of the 12 week treatment period or until complete cicatrization of the treated ulcer. ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	November 2006
Study Completion Date:	April 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Experimental 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.

Arms

Assigned Interventions

1: Active Comparator

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.

2: Experimental

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.

Eligibility

Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860717

Locations

Brazil, Pará
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

Study Director:

Claudio G Salgado, Dr

Federal University of Pará

More Information

Publications:

Flemming K, Cullum N. Laser therapy for venous leg ulcers. Cochrane Database Syst Rev. 2000;(2):CD001182. Review.

Hopkins JT, McLoda TA, Seegmiller JG, David Baxter G. Low-Level Laser Therapy Facilitates Superficial Wound Healing in Humans: A Triple-Blind, Sham-Controlled Study. J Athl Train. 2004 Sep;39(3):223-229.

Schindl A, Schindl M, Pernerstorfer-Schön H, Mossbacher U, Schindl L. Low intensity laser irradiation in the treatment of recalcitrant radiation ulcers in patients with breast cancer--long-term results of 3 cases. Photodermatol Photoimmunol Photomed. 2000 Feb;16(1):34-7.

Lucas C, van Gemert MJ, de Haan RJ. Efficacy of low-level laser therapy in the management of stage III decubitus ulcers: a prospective, observer-blinded multicentre randomised clinical trial. Lasers Med Sci. 2003;18(2):72-7.

Franek A, Król P, Kucharzewski M. Does low output laser stimulation enhance the healing of crural ulceration? Some critical remarks. Med Eng Phys. 2002 Nov;24(9):607-15.

Schubert V. Effects of phototherapy on pressure ulcer healing in elderly patients after a falling trauma. A prospective, randomized, controlled study. Photodermatol Photoimmunol Photomed. 2001 Feb;17(1):32-8.

Pereira AN, Eduardo Cde P, Matson E, Marques MM. Effect of low-power laser irradiation on cell growth and procollagen synthesis of cultured fibroblasts. Lasers Surg Med. 2002;31(4):263-7.

Responsible Party:	Federal University of Pará ( Claudio Guedes Salgado )
Study ID Numbers:	FINEP 1460/03
Study First Received:	March 11, 2009
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00860717 History of Changes
Health Authority:	Brazil: Ethics Committee

Keywords provided by Para Federal University:

Leprosy
Ulcers
Laser

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Silver Sulfadiazine
Ulcer

Mycobacterium Infections
Sulfadiazine
Leprosy

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Actinomycetales Infections
Leprosy

ClinicalTrials.gov processed this record on May 07, 2009