Diabetic Foot UlcerNCT04246814
Use of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers
A study testing LG1, LG2 and LG3 in people with Diabetic Foot Ulcer and Diabetic Foot, run by Federal University of Piaui at 1 site in Brazil.
Trial summary
Diabetes mellitus (DM) is currently an important cause of morbidity and mortality. Global estimates indicate that 382 million people live with diabetes (8.3%), and that number could reach 592 million in 2035. The diabetic foot ulcers (DFU) present as sore wounds with disintegration of the skin. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetic Foot
- What is being tested?
- LG1, LG2 and LG3
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Aug 2019to 18 Aug 2023
- 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 to 79 years
- 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
- Type 2 diabetes mellitus patients with ulcers in parts of the body other than the feet;
- Patients with infected diabetic foot ulcers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers: a Double-blind Randomized Controlled Trial
Diabetes mellitus (DM) is currently an important cause of morbidity and mortality. Global estimates indicate that 382 million people live with diabetes (8.3%), and that number could reach 592 million in 2035. The diabetic foot ulcers (DFU) present as sore wounds with disintegration of the skin. The DFU affect 15% of diabetic patients. Several studies have been conducted aiming to find therapeutic strategies for the healing of DFU, among the reported therapeutic methods the Low-level Laser Therapy (LLLT) has been highlighted. The aim of this study is to investigate the effects of different doses of LLLT in the treatment of DFU. Methods: This study is characterized as a double-blind randomized clinical trial (RCT), consisting of four groups, the control group will have only dressing and placebo LLLT application and the other three groups will have dressing and real LLLT GaAs 904 nm application. Expected outcomes: to elucidate the effects of different doses of LLLT GaAs 904 nm on the treatment of DFU, beyond to identify the most effective dose.
Read the detailed description
All groups will perform the same procedures twice weekly. Volunteers will be comfortable with the affected foot exposed. The diabetic foot ulcers (DFU) will be cleaned using saline solution and gauze, then the ulcer temperature will be checked using the digital infrared thermometer. Diabetic wounds will be measured and photographed at baseline and every 10 visits until the study is completed, the images will be analyzed using the ImageJ program for follow-up throughout the intervention. The DFU will be ranked according to the Wagner Scale. Afterwards the volunteers will receive LLLT application and conventional treatment in the form of Helianthus Annuus oil dressing. Both therapist and participant will be instructed on precautions to be observed when using LLLT. Goggles will be provided prior to administration. The lower cylinder of the LASER probe will be placed perpendicular to the DFU, the floor and edges of the ulcer will be irradiated using punctual and scanning techniques, respectively. Once a week blood glucose levels will be obtained for patient screening. All data will be recorded until the end of the visits in a control form prepared.
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot
- Being tested
- LG1, LG2, LG3, CC, Dressing
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LG1Device
Application of LASER AsGa 904nm 10 J/cm².
LG2Device
Application of LASER AsGa 904nm 8 J/cm².
LG3Device
Application of LASER AsGa 904nm 4 J/cm².
CCDevice
Application of placebo LASER.
DressingProcedure or surgery
Application of Helianthus annuus oil dressing.
| Study group | Role | What they receive |
|---|---|---|
| CC + dressing | Placebo comparator | The group will receive placebo LASER application associated with Helianthus annuus oil dressing. Receives: Device: CC; Procedure: Dressing |
| LG1 + dressing | Active comparator | The group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 10 J/cm² associated with Helianthus annuus oil dressing. Receives: Device: LG1; Procedure: Dressing |
| LG2 + dressing | Active comparator | The group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 8 J/cm² associated with Helianthus annuus oil dressing. Receives: Device: LG2; Procedure: Dressing |
| LG3 + dressing | Active comparator | The group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 4 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.
Secondary outcomes (4)
Wagner Classification
Ulcer categorization according to Wagner Classification.
Measured: Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.
Blood glucose
Glycemic levels.
Measured: Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.
Temperature
Ulcer temperature.
Measured: Before intervention starts, 5th and 10th week of intervention.
Short Form-36 Health Survey questionnaire
The Short Form-36 Health Survey questionnaire (SF 36) assesses quality of life and consists of 36 questions, covering 8 domains. This questionnaire has a final score from 0 to 100, in which zero corresponds to the worst general health status and 100 to the best health status.
Measured: Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start27 Aug 2019
- Primary completion18 Aug 2021
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246814
- Sponsor's protocol ID
- 17081119.1.0000.5214
- Status last verified
- Feb 2024
- First submitted
- 22 Jan 2020
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saura Cardoso V, de Souza Lima da Silveira PR, Dos Santos CM, Miranda MB, Silva Barros AC, Veloso LC, Magalhaes AT, da Rocha RB, Hazime FA. Dose-response and efficacy of 904 nm photobiomodulation on diabetic foot ulcers healing: a randomized controlled trial. Lasers Med Sci. 2024 May 28;39(1):142. doi: 10.1007/s10103-024-04090-3.
PubMed 38805069Cardoso VS, de Souza Lima da Silveira PR, Dos Santos CM, da Rocha RB, Hazime FA. Dose-response and efficacy of low-level laser therapy on diabetic foot ulcers healing: Protocol of a randomized controlled trial. Contemp Clin Trials. 2021 Nov;110:106561. doi: 10.1016/j.cct.2021.106561. Epub 2021 Sep 4.
PubMed 34487920
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04246814
- Acronym / sponsor ID
- 17081119.1.0000.5214
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Federal University of PiauiUniversity, hospital or other
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 29 Jan 2020 (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 (DM) is currently an important cause of morbidity and mortality. Global estimates indicate that 382 million people live with diabetes (8.3%), and that number could reach 592 million in 2035. The diabetic foot ulcers (DFU) present as sore wounds with disintegration of the skin. The DFU affect 15% of diabetic patients. Several studies have been conducted aiming to find therapeutic strategies for the healing of DFU, among the reported therapeutic methods the Low-level Laser Therapy (LLLT) has been highlighted. The aim of this study is to investigate the effects of different doses of LLLT in the treatment of DFU. Methods: This study is characterized as a double-blind randomized clinical trial (RCT), consisting of four groups, the control group will have only dressing and placebo LLLT application and the other three groups will have dressing and real LLLT GaAs 904 nm application. Expected outcomes: to elucidate the effects of different doses of LLLT GaAs 904 nm on the treatment of DFU, beyond to identify the most effective dose.
Detailed description
All groups will perform the same procedures twice weekly. Volunteers will be comfortable with the affected foot exposed. The diabetic foot ulcers (DFU) will be cleaned using saline solution and gauze, then the ulcer temperature will be checked using the digital infrared thermometer. Diabetic wounds will be measured and photographed at baseline and every 10 visits until the study is completed, the images will be analyzed using the ImageJ program for follow-up throughout the intervention. The DFU will be ranked according to the Wagner Scale. Afterwards the volunteers will receive LLLT application and conventional treatment in the form of Helianthus Annuus oil dressing. Both therapist and participant will be instructed on precautions to be observed when using LLLT. Goggles will be provided prior to administration. The lower cylinder of the LASER probe will be placed perpendicular to the DFU, the floor and edges of the ulcer will be irradiated using punctual and scanning techniques, respectively. Once a week blood glucose levels will be obtained for patient screening. All data will be recorded until the end of the visits in a control form prepared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CC + dressing | Placebo comparator | Device: CC, Procedure: DressingThe group will receive placebo LASER application associated with Helianthus annuus oil dressing. |
| LG1 + dressing | Active comparator | Device: LG1, Procedure: DressingThe group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 10 J/cm² associated with Helianthus annuus oil dressing. |
| LG2 + dressing | Active comparator | Device: LG2, Procedure: DressingThe group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 8 J/cm² associated with Helianthus annuus oil dressing. |
| LG3 + dressing | Active comparator | Device: LG3, Procedure: DressingThe group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 4 J/cm² associated with Helianthus annuus oil dressing. |
Who may qualify
- Ages
- 18 to 79 years
- 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 (2 listed)
- Type 2 diabetes mellitus patients with ulcers in parts of the body other than the feet;
- 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 |
|---|---|---|
| LG1Application of LASER AsGa 904nm 10 J/cm². | Device | LG1 + dressing |
| LG2Application of LASER AsGa 904nm 8 J/cm². | Device | LG2 + dressing |
| LG3Application of LASER AsGa 904nm 4 J/cm². | Device | LG3 + dressing |
| CCApplication of placebo LASER. | Device | CC + dressing |
| DressingApplication of Helianthus annuus oil dressing. | Procedure or surgery | CC + dressing, LG1 + dressing, LG2 + dressing, LG3 + dressing |
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.
4 secondary outcomes
Wagner Classification
Time frame: Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.
Blood glucose
Time frame: Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.
Temperature
Time frame: Before intervention starts, 5th and 10th week of intervention.
Short Form-36 Health Survey questionnaire
Time frame: Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month.
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 22 Feb 2024.
- Derived from this study: PubMed 38805069Saura Cardoso V, de Souza Lima da Silveira PR, Dos Santos CM, Miranda MB, Silva Barros AC, Veloso LC, Magalhaes AT, da Rocha RB, Hazime FA. Dose-response and efficacy of 904 nm photobiomodulation on diabetic foot ulcers healing: a randomized controlled trial. Lasers Med Sci. 2024 May 28;39(1):142. doi: 10.1007/s10103-024-04090-3.
- Derived from this study: PubMed 34487920Cardoso VS, de Souza Lima da Silveira PR, Dos Santos CM, da Rocha RB, Hazime FA. Dose-response and efficacy of low-level laser therapy on diabetic foot ulcers healing: Protocol of a randomized controlled trial. Contemp Clin Trials. 2021 Nov;110:106561. doi: 10.1016/j.cct.2021.106561. Epub 2021 Sep 4.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LG1, LG2 and LG3 in people with Diabetic Foot Ulcer 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 2 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 22 Feb 2024. 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 NCT04246814, which also lists 2 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 22 Feb 2024.