Clinical trial NCT00860717: The Use of Low Level Laser Therapy for Wound Healing in Leprosy Patients
Official title: Clinic-Epidemiological Evaluation of Ulcers in Leprosy Patients and the Use of Low Level Laser Therapy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leprosy
Keywords: Leprosy
Ulcers
Laser
Lead sponsor: Para Federal University
Sponsor class: OTHER
First posted: 2009-03-12
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Wound healing
timeFrame: Biweekly until the end of the 12 week treatment period.
Secondary outcomes:
measure: Ulcer surface area, depth and PUSH tool score.
timeFrame: Biweekly until the end of the 12 week treatment period or until complete cicatrization of the treated ulcer.
Other outcomes:
Locations:
city: Marituba
country: Brazil
facility: Dr. Marcello Candia Reference Unit in Sanitary Dermatology of the State of Pará in Brazil (UREMC)
state: Pará
Study officials:
affiliation: Federal University of Pará
name: Claudio G Salgado, Dr
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.