LeprosyNCT00860717
The Use of Low Level Laser Therapy for Wound Healing in Leprosy Patients
A study testing Routine treatment and Low level laser therapy (LLLT) in people with Leprosy, run by Para Federal University at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leprosy
- What is being tested?
- Routine treatment and Low level laser therapy (LLLT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2006to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Dr. Marcello Candia Reference Unit in Sanitary Dermatology of the State of Pará in Brazil (UREMC)
Marituba, Pará, 67200-000
About this study
Official title: Clinic-Epidemiological Evaluation of Ulcers in Leprosy Patients and the Use of Low Level Laser Therapy: a Randomized Clinical Trial
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
- Being tested
- Routine treatment, Low level laser therapy (LLLT)
- Keywords
- Leprosy, Ulcers, Laser
- Medical subject headings
- Leprosy, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine treatmentProcedure or surgery
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.
Low level laser therapy (LLLT)Radiation
Also called LLLT, Cold laser, LILT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: Low level laser therapy (LLLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Measured: Biweekly until the end of the 12 week treatment period.
Secondary outcomes (1)
Ulcer surface area, depth and PUSH tool score.
Measured: Biweekly until the end of the 12 week treatment period or until complete cicatrization of the treated ulcer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startNov 2006
- Primary completionJan 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for LeprosyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Para Federal University
- Sponsor type
- University, hospital or other
- Investigators
- Claudio G Salgado, Dr, Study director, Federal University of Pará
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860717
- Sponsor's protocol ID
- FINEP 1460/03
- Status last verified
- Mar 2009
- First submitted
- 11 Mar 2009
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Flemming K, Cullum N. Laser therapy for venous leg ulcers. Cochrane Database Syst Rev. 2000;(2):CD001182. doi: 10.1002/14651858.CD001182.
PubMed 10796615Hopkins 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.
PubMed 15496990Schindl 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.
PubMed 10721863Lucas 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.
PubMed 12928815Franek 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.
PubMed 12376047Schubert 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.
PubMed 11169174Pereira 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.
PubMed 12355572Barreto 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.
PubMed 20698989
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic-Epidemiological Evaluation of Ulcers in Leprosy Patients and the Use of Low Level Laser Therapy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00860717
- Acronym / sponsor ID
- FINEP 1460/03
- Conditions
- Leprosy
- Keywords
- Leprosy, Ulcers, Laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Para Federal UniversityUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 12 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Routine treatmentSubjects 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. |
| 2 | Experimental | Radiation: Low level laser therapy (LLLT)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine treatmentSubjects 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. | Procedure or surgery | 1 |
| Low level laser therapy (LLLT)Also: LLLT, Cold laser, LILTThe 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. | Radiation | 2 |
Primary outcome
Wound healing
Time frame: Biweekly until the end of the 12 week treatment period.
1 secondary outcome
Ulcer surface area, depth and PUSH tool score.
Time frame: Biweekly until the end of the 12 week treatment period or until complete cicatrization of the treated ulcer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2009.
- Background: PubMed 10796615Flemming K, Cullum N. Laser therapy for venous leg ulcers. Cochrane Database Syst Rev. 2000;(2):CD001182. doi: 10.1002/14651858.CD001182.
- Background: PubMed 15496990Hopkins 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.
- Background: PubMed 10721863Schindl 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.
- Background: PubMed 12928815Lucas 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.
- Background: PubMed 12376047Franek 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.
- Background: PubMed 11169174Schubert 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.
- Background: PubMed 12355572Pereira 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.
- Derived from this study: PubMed 20698989Barreto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio G Salgado, Dr study director
Federal University of Pará
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine treatment and Low level laser therapy (LLLT) in people with Leprosy, run by Para Federal University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: Biweekly until the end of the 12 week treatment period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00860717, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2009.