WoundNCT05530486
Effect of the Use of Low Intensity Therapeutic LASER
A study testing CC, LG1 and LG2 in people with Wound and Diabetic Foot, run by Federal University of Piaui at 1 site in Brazil.
Trial summary
Diabetes mellitus consists of a heterogeneous group of metabolic disorders that have hyperglycemia in common, resulting from defects in insulin action, insulin secretion, or both. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound, Diabetic Foot, LTBI
- What is being tested?
- CC, LG1 and LG2
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jun 2023to 30 May 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus patients with diabetic foot ulcers;
- Patients aged 18 and over.
Who cannot join
- Patients with autoimmune diseases
- Patients with concomitant psychiatric disorders
- Patients with contraindications to treatment methods
- Patients with infected diabetic foot ulcers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Use of Therapeutic Low-intensity 660 nm LASER in the Treatment of Diabetic Ulcers: a Double-blind Randomized Clinical Trial
Diabetes mellitus consists of a heterogeneous group of metabolic disorders that have hyperglycemia in common, resulting from defects in insulin action, insulin secretion, or both. Diabetes mellitus has gained increasing importance and is considered one of the main themes of global health problems due to the damage caused to quality of life, public health and the epidemiological picture presented. Among the complications are diabetic foot ulcers, with higher prevalence in the lower limbs, they are classified as loss of skin continuity, which can reach from the epidermis to deep structures such as muscles, bones and tendons.
Read the detailed description
100 volunteers will be recruited and the research will be carried out through the Integrated Center of Medical Specialties (CIEM) - Polyclinic, through referral from the specialist in vascular surgery after a thorough examination of the feet. Volunteers of both sexes, aged over 18 years, DM and diabetic ulcers will be admitted. Volunteers who present any autoimmune disease, concomitant psychiatric disorders or contraindications to the treatment methods adopted by the research will be excluded. Inclusion in the study will take place after signing the informed consent forms, after approval by the Ethics Committee.
- Conditions
- Wound, Diabetic Foot, LTBI
- Being tested
- CC, LG1, LG2, LG3, Dressing
- Keywords
- Diabetes Mellitus, Low-Level Light Therapy, Diabetic Foot
- Medical subject headings
- Wounds and Injuries, Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCDevice
Application of placebo LASER
LG1Device
Application of LASER GasAs 660nm 4 J/cm².
LG2Device
Application of LASER GasAs 660nm 8 J/cm².
LG3Device
Application of LASER GasAs 660nm 12 J/cm².
DressingProcedure or surgery
Application of Helianthus annuus oil dressing.
| Study group | Role | What they receive |
|---|---|---|
| Comparador de placebo: CC + curativo | Placebo comparator | The group will receive placebo LASER application associated with Helianthus annuus oil dressing. Receives: Device: CC; Procedure: Dressing |
| Comparador ativo: LG1 + curativo | Active comparator | The group will receive application of LASER Gallium Arsenide (GasAs) 660 nm 4 J/cm² associated with Helianthus annuus oil dressing. Receives: Device: LG1; Procedure: Dressing |
| Comparador ativo: LG2 + curativo | Active comparator | The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 8 J/cm² associated with Helianthus annuus oil dressing. Receives: Device: LG2; Procedure: Dressing |
| Comparador ativo: LG3 + curativo | Active comparator | The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 12 J/cm² associated with Helianthus annuus oil dressing. Receives: Device: LG3; Procedure: Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the ulcer area
Measure of ulcer area change.
Measured: Before intervention starts, 5th and 10th week of intervention.
Change in complete ulcer healing
Change in the percentage of complete ulcer healing.
Measured: Before intervention starts, 5th and 10th week of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start30 Jun 2023
- Primary completion30 May 2025
- Study completion30 May 2025
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 WoundStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Piaui
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinicius Saura Cardoso, Federal University of Piaui
- Investigators
- Vinicius Saura Cardoso, Principal investigator, Federal University of Piaui
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530486
- Sponsor's protocol ID
- 5.588.474
- Status last verified
- Mar 2024
- First submitted
- 1 Sep 2022
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bezerra Miranda M, Silva Barros AC, Veloso Coelho L, Barbosa da Rocha R, Antonio Kato da Silva B, Ahmad Hazime F, Tanuri Magalhaes A, Saura Cardoso V. Dose-response and efficacy of 660-nanometer low-level laser therapy in healing diabetic foot ulcers: a randomized, double-blind, clinical trial. Lasers Med Sci. 2025 Oct 1;40(1):399. doi: 10.1007/s10103-025-04641-2.
PubMed 41028567
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Use of Therapeutic Low-intensity 660 nm LASER in the Treatment of Diabetic Ulcers: a Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05530486
- Acronym / sponsor ID
- 5.588.474
- Conditions
- Wound, Diabetic Foot, LTBI
- Keywords
- Diabetes Mellitus, Low-Level Light Therapy, Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federal University of PiauiUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 7 Sep 2022 (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.
Diabetes mellitus consists of a heterogeneous group of metabolic disorders that have hyperglycemia in common, resulting from defects in insulin action, insulin secretion, or both. Diabetes mellitus has gained increasing importance and is considered one of the main themes of global health problems due to the damage caused to quality of life, public health and the epidemiological picture presented. Among the complications are diabetic foot ulcers, with higher prevalence in the lower limbs, they are classified as loss of skin continuity, which can reach from the epidermis to deep structures such as muscles, bones and tendons.
Detailed description
100 volunteers will be recruited and the research will be carried out through the Integrated Center of Medical Specialties (CIEM) - Polyclinic, through referral from the specialist in vascular surgery after a thorough examination of the feet. Volunteers of both sexes, aged over 18 years, DM and diabetic ulcers will be admitted. Volunteers who present any autoimmune disease, concomitant psychiatric disorders or contraindications to the treatment methods adopted by the research will be excluded. Inclusion in the study will take place after signing the informed consent forms, after approval by the Ethics Committee.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Comparador de placebo: CC + curativo | Placebo comparator | Device: CC, Procedure: DressingThe group will receive placebo LASER application associated with Helianthus annuus oil dressing. |
| Comparador ativo: LG1 + curativo | Active comparator | Device: LG1, Procedure: DressingThe group will receive application of LASER Gallium Arsenide (GasAs) 660 nm 4 J/cm² associated with Helianthus annuus oil dressing. |
| Comparador ativo: LG2 + curativo | Active comparator | Device: LG2, Procedure: DressingThe group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 8 J/cm² associated with Helianthus annuus oil dressing. |
| Comparador ativo: LG3 + curativo | Active comparator | Device: LG3, Procedure: DressingThe group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 12 J/cm² associated with Helianthus annuus oil dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetes mellitus patients with diabetic foot ulcers;
- Patients aged 18 and over.
Key exclusion criteria (4 listed)
- Patients with autoimmune diseases
- Patients with concomitant psychiatric disorders
- Patients with contraindications to treatment methods
- Patients with infected diabetic foot ulcers.
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 |
|---|---|---|
| CCApplication of placebo LASER | Device | Comparador de placebo: CC + curativo |
| LG1Application of LASER GasAs 660nm 4 J/cm². | Device | Comparador ativo: LG1 + curativo |
| LG2Application of LASER GasAs 660nm 8 J/cm². | Device | Comparador ativo: LG2 + curativo |
| LG3Application of LASER GasAs 660nm 12 J/cm². | Device | Comparador ativo: LG3 + curativo |
| DressingApplication of Helianthus annuus oil dressing. | Procedure or surgery | Comparador ativo: LG1 + curativo, Comparador ativo: LG2 + curativo, Comparador ativo: LG3 + curativo, Comparador de placebo: CC + curativo |
Primary outcome
Change in the ulcer area
Time frame: Before intervention starts, 5th and 10th week of intervention.
Measure of ulcer area change.
Change in complete ulcer healing
Time frame: Before intervention starts, 5th and 10th week of intervention.
Change in the percentage of complete ulcer healing.
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 12 Jun 2025.
- Derived from this study: PubMed 41028567Bezerra Miranda M, Silva Barros AC, Veloso Coelho L, Barbosa da Rocha R, Antonio Kato da Silva B, Ahmad Hazime F, Tanuri Magalhaes A, Saura Cardoso V. Dose-response and efficacy of 660-nanometer low-level laser therapy in healing diabetic foot ulcers: a randomized, double-blind, clinical trial. Lasers Med Sci. 2025 Oct 1;40(1):399. doi: 10.1007/s10103-025-04641-2.
- Individual participant dataSharing planned: No
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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.
Vinicius Saura Cardoso principal investigator
Federal University of Piaui
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CC, LG1 and LG2 in people with Wound and Diabetic Foot, run by Federal University of Piaui 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 2 inclusion and 4 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 12 Jun 2025. 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. Some participants in this study may receive a placebo. 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?
Change in the ulcer area (time frame: Before intervention starts, 5th and 10th week of intervention.). The study lists 2 primary outcomes in all. 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 NCT05530486, 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 12 Jun 2025.