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Clinical Trials/NCT00860717
NCT00860717CompletedNot Applicable

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

Para Federal University2 sites in 1 country25 target enrollmentStarted: November 1, 2006Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
25
Locations
2
Primary Endpoint
Wound healing
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Wound healing

Time Frame: Biweekly until the end of the 12 week treatment period.

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Para Federal University
Sponsor Class
Other

Study Sites (2)

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