The Use of Low Level Laser Therapy for Wound Healing in Leprosy Patients
Information source: Para Federal University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leprosy
Intervention: Routine treatment (Procedure); Low level laser therapy (LLLT) (Radiation)
Phase: N/A
Status: Completed
Sponsored by: Para Federal University Official(s) and/or principal investigator(s): Claudio G Salgado, Dr, Study Director, Affiliation: Federal University of Pará
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.
Clinical Details
Official title: Clinic-Epidemiological Evaluation of Ulcers in Leprosy Patients and the Use of Low Level Laser Therapy: a Randomized Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Wound healing
Secondary outcome: Ulcer surface area, depth and PUSH tool score.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Dr. Marcello Candia Reference Unit in Sanitary Dermatology of the State of Pará in Brazil (UREMC), Marituba, Pará 67200-000, Brazil
Additional Information
Related publications: Flemming K, Cullum N. Laser therapy for venous leg ulcers. Cochrane Database Syst Rev. 2000;(2):CD001182. Review. Update in: Cochrane Database Syst Rev. 2014;7: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-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.
Starting date: November 2006
Last updated: December 12, 2009
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