Venous UlcerLASERUVeNCT03229330
Low-level Light Therapy on Treatment of Venous Ulcers Assesed by Nursing Outcome Classification (NOC)
A study testing Low-level Light Therapy and Conventional treatment in people with Venous Ulcer and Low-Level Light Therapy, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This study compares the effect of adjuvant treatment of Low-level Light Therapy with conventional treatment in the tissue repair of venous ulcers in patients undergoing outpatient nursing consultation. For the evaluation of the cases clinical indicators of Nursing Outcomes Classification have been used. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Venous Ulcer, Low-Level Light Therapy
- What is being tested?
- Low-level Light Therapy and Conventional treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2016to Dec 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of venous ulcer
- Availability for weekly appointment
- Acceptance to participate of the research with the signature of the Term of Free and Informed Consent
Who cannot join
- Morbid obesity
- Active cancer treatment
- Erysipelas
- Cellulitis, lymphangitis and chronic lymphedema
- Usage of immunosuppressants and / or corticosteroids
- Venous ulcer all around the leg
- Presence of coagulation necrosis covering more than 25% of the wound bed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: The Effect of Low-level Light Therapy on Treatment of Venous Ulcers Assessed by Nursing Outcomes Classification (NOC): Randomized Clinical Trial
This study compares the effect of adjuvant treatment of Low-level Light Therapy with conventional treatment in the tissue repair of venous ulcers in patients undergoing outpatient nursing consultation. For the evaluation of the cases clinical indicators of Nursing Outcomes Classification have been used.
Read the detailed description
There are several therapeutics with different mechanisms of action to reach tissue repair.
The conventional treatment of venous ulcers is based on the alternation of exercising the lower extremities with resting, the application of topical treatments associated with compressive therapy, and the use of medications.
Despite the diversity of bandages available, there are still lesions with difficult prolonged healing process. Therefore, Low-level Light Therapy has been used as an adjuvant technological alternative therapy, due to its photochemical effects on the tissues, such as the modulation of inflammation, increase of granulation tissue, contraction of the wound, reduction of the inflammatory process, and reduction of pain. This therapy contributes to accelerate and improve the tissue repair process.
Studies assessed by Nursing Outcomes Classification about the usage of the treatments above combined are not available. Consequently, more robust clinical studies over venous ulcers to evaluate the tissue repair must be proposed using reliable instruments.
- Conditions
- Venous Ulcer, Low-Level Light Therapy
- Being tested
- Low-level Light Therapy, Conventional treatment
- Keywords
- Wound Healing, Outcome Assessment (Health Care)
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level Light TherapyProcedure or surgery
Also called Wavelength of 660 nm, red laser
Low-level Light Therapy 660nm (red laser), 1 to 3 Joules, irradiation time and number of points varied.
Conventional treatmentCombination product
Also called Topical and compressive treatments
Topical treatment: essential fatty oil, hydrogel, papain gel, petrolatum gauze, calcium or silver alginate, zinc oxide and barrier cream; and high compression bandage SurePress
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Low-level Light Therapy: Wavelength of 660 nm (red laser) and Conventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks. Receives: Procedure: Low-level Light Therapy; Combination Product: Conventional treatment |
| Controls | Active comparator | Conventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks. Receives: Combination Product: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased Wound Size and Scar formation
NOC Wound Healing: Second Intention - Greater length (in the cephalopheudial direction) versus greater width, in cm2 evaluated by the Likert scale, being 1 the worst score and 5 best score.
NOC Wound Healing: Second Intention - Wound covered with epithelial tissue (new pink or bright tissue that develops from the edges or as "islands" on the surface of the lesion) evaluated by the Likert scale, being 1 the worst score and 5 best score.
Measured: 16 weeks
Secondary outcomes (3)
Skin thickness
NOC Tissue Integrity: Skin and Mucous Membranes - Depth reached. It involves layers and structures of the skin altered by loss of tissue integrity (ulcerated area) assessed by the Likert scale, being 1 the worst score and 5 best score.
Measured: 16 weeks
Evaluation of Pain
NOC Tissue Integrity: Skin and Mucous Membranes - Unpleasant sensory and emotional experience arising from actual or potential or described tissue injury, with sudden or slow onset of mild to severe intensity, constant or recurrent, without an anticipated or predictable termination. Evaluated as frequency, condition and intensity by the Likert scale, being 1 the worst score and 5 best score.
Measured: 16 weeks
Overall improvement of other NOC indicators correlated.
Overall improvement of the indicators of NOC results of Wound Healing: Second Intention and Tissue Integrity: Skin and Mucous Membranes.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study startApr 2016
- Primary completionJul 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous UlcerStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amália De Fátima Lucena, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229330
- Sponsor's protocol ID
- 15-0634
- Acronym
- LASERUVe
- Status last verified
- Jul 2017
- First submitted
- 21 Jul 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bavaresco T, Pires AUB, Moraes VM, Osmarin VM, Silveira DT, Lucena AF. Low-level laser therapy for treatment of venous ulcers evaluated with the Nursing Outcome Classification: study protocol for a randomized controlled trial. Trials. 2018 Jul 12;19(1):372. doi: 10.1186/s13063-018-2729-x.
PubMed 30001202
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low-level Light Therapy on Treatment of Venous Ulcers Assessed by Nursing Outcomes Classification (NOC): Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03229330
- Acronym / sponsor ID
- LASERUVe / 15-0634
- Conditions
- Venous Ulcer, Low-Level Light Therapy
- Keywords
- Wound Healing, Outcome Assessment (Health Care)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 Jul 2017 (actual)
- 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.
This study compares the effect of adjuvant treatment of Low-level Light Therapy with conventional treatment in the tissue repair of venous ulcers in patients undergoing outpatient nursing consultation. For the evaluation of the cases clinical indicators of Nursing Outcomes Classification have been used.
Detailed description
There are several therapeutics with different mechanisms of action to reach tissue repair.
The conventional treatment of venous ulcers is based on the alternation of exercising the lower extremities with resting, the application of topical treatments associated with compressive therapy, and the use of medications.
Despite the diversity of bandages available, there are still lesions with difficult prolonged healing process. Therefore, Low-level Light Therapy has been used as an adjuvant technological alternative therapy, due to its photochemical effects on the tissues, such as the modulation of inflammation, increase of granulation tissue, contraction of the wound, reduction of the inflammatory process, and reduction of pain. This therapy contributes to accelerate and improve the tissue repair process.
Studies assessed by Nursing Outcomes Classification about the usage of the treatments above combined are not available. Consequently, more robust clinical studies over venous ulcers to evaluate the tissue repair must be proposed using reliable instruments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Low-level Light Therapy, Combination Product: Conventional treatmentLow-level Light Therapy: Wavelength of 660 nm (red laser) and Conventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks. |
| Controls | Active comparator | Combination Product: Conventional treatmentConventional treatment: Topical treatment with compressive therapy, exercises of lower extremities, resting; once a week for 16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of venous ulcer
- Availability for weekly appointment
- Acceptance to participate of the research with the signature of the Term of Free and Informed Consent
Key exclusion criteria (7 listed)
- Morbid obesity
- Active cancer treatment
- Erysipelas
- Cellulitis, lymphangitis and chronic lymphedema
- Usage of immunosuppressants and / or corticosteroids
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 |
|---|---|---|
| Low-level Light TherapyAlso: Wavelength of 660 nm, red laserLow-level Light Therapy 660nm (red laser), 1 to 3 Joules, irradiation time and number of points varied. | Procedure or surgery | Intervention |
| Conventional treatmentAlso: Topical and compressive treatmentsTopical treatment: essential fatty oil, hydrogel, papain gel, petrolatum gauze, calcium or silver alginate, zinc oxide and barrier cream; and high compression bandage SurePress | Combination product | Controls, Intervention |
Primary outcome
Decreased Wound Size and Scar formation
Time frame: 16 weeks
NOC Wound Healing: Second Intention - Greater length (in the cephalopheudial direction) versus greater width, in cm2 evaluated by the Likert scale, being 1 the worst score and 5 best score. NOC Wound Healing: Second Intention - Wound covered with epithelial tissue (new pink or bright tissue that develops from the edges or as "islands" on the surface of the lesion) evaluated by the Likert scale, being 1 the worst score and 5 best score.
3 secondary outcomes
Skin thickness
Time frame: 16 weeks
Evaluation of Pain
Time frame: 16 weeks
Overall improvement of other NOC indicators correlated.
Time frame: 16 weeks
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 27 Feb 2019.
- Derived from this study: PubMed 30001202Bavaresco T, Pires AUB, Moraes VM, Osmarin VM, Silveira DT, Lucena AF. Low-level laser therapy for treatment of venous ulcers evaluated with the Nursing Outcome Classification: study protocol for a randomized controlled trial. Trials. 2018 Jul 12;19(1):372. doi: 10.1186/s13063-018-2729-x.
- Individual participant dataSharing planned: Undecided
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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.
Amália De Fátima Lucena principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level Light Therapy and Conventional treatment in people with Venous Ulcer and Low-Level Light Therapy, run by Hospital de Clinicas de Porto Alegre 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 3 inclusion and 7 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 27 Feb 2019. 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?
Decreased Wound Size and Scar formation (time frame: 16 weeks). 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 NCT03229330, which also lists 1 linked publication.
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 27 Feb 2019.