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

Leprosy Clinical Trial

Official title:

Clinic-Epidemiological Evaluation of Ulcers in Leprosy Patients and the Use of Low Level Laser Therapy: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860717
• Other study ID #: FINEP 1460/03
• Status: Completed
• Phase: N/A
• First received: March 11, 2009
• Last updated: December 12, 2009
• Start date: November 2006
• Est. completion date: April 2008

Study information

• Verified date: March 2009
• Source: Para Federal University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leprosy

Intervention

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.

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Para Federal University

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing		Biweekly until the end of the 12 week treatment period.	No
Secondary	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.	No