The Use of Low Level Laser Therapy for Wound Healing in Leprosy Patients
NCT ID: NCT00860717
Last Updated: 2009-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2006-11-30
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Para Federal University
OTHER
Responsible Party
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Federal University of Pará
Principal Investigators
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Claudio G Salgado, Dr
Role: STUDY_DIRECTOR
Federal University of Pará
Locations
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Dr. Marcello Candia Reference Unit in Sanitary Dermatology of the State of Pará in Brazil (UREMC)
Marituba, Pará, Brazil
Countries
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References
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Flemming K, Cullum N. Laser therapy for venous leg ulcers. Cochrane Database Syst Rev. 2000;(2):CD001182. doi: 10.1002/14651858.CD001182.
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-Schon 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. doi: 10.1034/j.1600-0781.2000.160109.x.
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. doi: 10.1007/s10103-003-0259-5.
Franek A, Krol 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. doi: 10.1016/s1350-4533(02)00112-1.
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. doi: 10.1034/j.1600-0781.2001.017001032.x.
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. doi: 10.1002/lsm.10107.
Barreto JG, Salgado CG. Clinic-epidemiological evaluation of ulcers in patients with leprosy sequelae and the effect of low level laser therapy on wound healing: a randomized clinical trial. BMC Infect Dis. 2010 Aug 10;10:237. doi: 10.1186/1471-2334-10-237.
Other Identifiers
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FINEP 1460/03
Identifier Type: -
Identifier Source: org_study_id