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

NCT00860717 | Completed

• 1 other identifier: FINEP 1460/03
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Leprosy

Keywords

Leprosy; Ulcers; Laser

Outcome Measures

Primary Outcomes (1)

• Wound healing

  Biweekly until the end of the 12 week treatment period.

Secondary Outcomes (1)

• Ulcer surface area, depth and PUSH tool score.

  Biweekly until the end of the 12 week treatment period or until complete cicatrization of the treated ulcer.

Study Arms (2)

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

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)

Interventions

Routine treatment PROCEDURE

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.

1

Low level laser therapy (LLLT) RADIATION

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.

Also known as: LLLT, Cold laser, LILT

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Para Federal University: lead

Study Sites (1)

Dr. Marcello Candia Reference Unit in Sanitary Dermatology of the State of Pará in Brazil (UREMC)

Marituba, Pará, 67200-000, Brazil

Location

Related Publications (8)

• Flemming K, Cullum N. Laser therapy for venous leg ulcers. Cochrane Database Syst Rev. 2000;(2):CD001182. doi: 10.1002/14651858.CD001182.

  PMID: 10796615 BACKGROUND

• 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.

  PMID: 15496990 BACKGROUND

• 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.

  PMID: 10721863 BACKGROUND

• 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.

  PMID: 12928815 BACKGROUND

• 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.

  PMID: 12376047 BACKGROUND

• 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.

  PMID: 11169174 BACKGROUND

• 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.

  PMID: 12355572 BACKGROUND

• 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.

  PMID: 20698989 DERIVED

MeSH Terms

Conditions

Leprosy; Ulcer

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Claudio G Salgado, Dr

  Federal University of Pará

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 12, 2009
• Study Start: November 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: April 1, 2008
• Last Updated: December 15, 2009

Record last verified: 2009-03

Locations

BR (1)