UlcerNCT03250533
Analysis of the Effects of LED Phototherapy and Electrical Stimulation in the Healing of Diabetic Ulcers
A study testing Light emitting diodes (LED) and Fixed diphasic current in people with Ulcer and Diabetes Mellitus, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
One of the important complications of DM is the diabetic foot that may present ulcers, which result from multiple risk factors, being diabetic peripheral neuropathy and ischemia due to peripheral vascular disease considered the main causes. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Ulcer, Diabetes Mellitus
- What is being tested?
- Light emitting diodes (LED) and Fixed diphasic current
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2017to 30 Jun 2021
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range from 30 to 65 years;
- Diabetic patients with neuropathic, ischemic or neuroischemic ulcers in the legs and / or feet;
- With a duration of 4 weeks or more;
- Being grade I and / or II lesions by the Meggitt-Wagner classification;
- Have a good degree of cognition evaluated by the Mini-Mental State Examination - MEEM (Brucki et al., 2003);
- Be under medical supervision and perform regular dressings and debridements of the wound.
Who cannot join
- Those presenting with an associated disease, such as renal, neurological, immunological, hematological or hepatic disease, which may interfere with evaluation and / or therapeutic procedures, and which are not related to diabetes;
- Malignancies (carcinomas);
- Use of medications that alter the healing process (corticosteroids, immunosuppressants, among others);
- Clinical signs of infection (sepsis), acute cellulitis, osteomyelitis or gangrene;
- Those who do not agree to sign the Free and Informed Consent Form;
- And who do not meet the inclusion criteria described.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Effects of Phototherapy With Light-emitting Diodes (LED) and Electrical Stimulation in the Healing of Ulcers of Lower Diabetic Limbs: a Blind Controlled Randomized Clinical Test
One of the important complications of DM is the diabetic foot that may present ulcers, which result from multiple risk factors, being diabetic peripheral neuropathy and ischemia due to peripheral vascular disease considered the main causes. In this way, the ulcers of the lower extremities of diabetics, have a complex and long cicatrization process. Faced with this, the treatment of chronic wounds is challenging, the diversity of treatments is great, however the search for new modalities of effective therapeutic resources, scientifically proven and financially feasible, that are available and easily accessible for clinical practice is still desirable . The aim of this study was to evaluate the responses of phototherapy with light emitting diodes (LED) and electrical stimulation with the fixed diphasic current (DF) in ulcers of diabetic patients. Diabetic volunteers who present with chronic skin ulcers will also be randomized (n = 13) to: Treatment group with LED 620 nm, Treatment group with LED 940 nm, Treatment group with fixed diphasic current and Control group. Interventions will occur three times a week for 12 weeks and evaluations will occur on the 1st, 30th, 60th, and 90th day of the intervention, followed by follow-up after 30 days of treatment completion.
Read the detailed description
Background: Diabetes mellitus (DM) is a chronic disease currently considered a worldwide epidemic and has become a major public health problem. One of the important complications of DM is the diabetic foot that may present ulcers, which result from multiple risk factors, being diabetic peripheral neuropathy and ischemia due to peripheral vascular disease considered the main causes. In this way, the ulcers of the lower extremities of diabetics, have a complex and long healing process, as they present a reduction in the angiogenic response and deficiency of growth factors, making difficult the action of conventional treatments. The treatment of chronic wounds is challenging, the diversity of treatments is great, however the search for new modalities of effective, scientifically proven and financially viable therapeutic resources that are available and readily accessible to clinical practice is still desirable. Objective: To evaluate the responses of phototherapy with light emitting diodes (LED) and electrical stimulation with the fixed diphasic current (DF) in diabetic patient ulcers. METHODS: Diabetic volunteers of both genders, aged 30 to 65 years, who present chronic skin ulcers grade I or II will also be randomized (n = 13) in: Treatment group with LED 620 nm (G-LED 620) , Treatment group with LED 940 nm (G-LED 940), Treatment group with fixed diphasic current (G-DF) and Control group (GC). Interventions will occur three times a week for 12 weeks. The evaluations will take place on the pre-intervention day 1, 30, 60 and 90 days, followed by follow-up after 30 days of the end of the treatment, through the following instruments: numerical scale of pain, digital photography, infrared thermography, digital analgesimeter, Digital durometer, infrared plethysmography and bioimpedance. Statistical analysis: To analyze the data, normality test will be used to verify the distribution of the data and adequate statistical test for the appropriate inter- and intragroup comparisons, being thus considered two factors in the comparisons, time and group. A significance level of 5% will be adopted.
- Conditions
- Ulcer, Diabetes Mellitus
- Being tested
- Light emitting diodes (LED), Fixed diphasic current
- Keywords
- Wound healing, Phototherapy, Electrotherapy
- Medical subject headings
- Ulcer, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light emitting diodes (LED)Device
The light-emitting diode (LED) device consists of a soft 15 x 15 cm blanket, which allows the body segment curvature of the cutaneous lesion to be monitored. The LEDs are fixed equidistant to obtain uniform irradiation over the entire ulcer. The wound site will be surrounded by a PVC film (polyvinyl chloride), to avoid contamination, for posterior positioning of the LED device, applying light directly and perpendicularly, with energy density of 6 J / cm². All LEDs will be calibrated prior to the start of applications in the Laboratory of Photobiophysics of the Faculty of Sciences and Letters of Ribeirão Preto, University of São Paulo, in which the wavelengths will be checked, the angle of radiation, power and power density.
Fixed diphasic currentDevice
The electrical stimulation treatment will be performed with the fixed diphasic current of the Dualpex 071 equipment (Quark®, Piracicaba, SP, Brazil), with the monopolar technique, 100 Hz, maximum intensity of 1 mA / cm² of lesion for 10 minutes. Autoclave sterilized aluminum electrodes will be used, one on the lesion (negative pole) and the other transversal to the segment (positive pole). The size of the electrode will be proportional to the extension of the lesion, having as a means of contact between the electrode and the ulcer, sterile gauze moistened with 0.9% saline solution.
| Study group | Role | What they receive |
|---|---|---|
| LED 620 nm group (G-LED 620) | Experimental | The LED device in the red light spectrum, with a wavelength of 620 nm, will be applied over the full extent of the wound. Receives: Device: Light emitting diodes (LED) |
| LED 940 nm group (G-LED 940) | Experimental | The LED device in the infrared light spectrum, with a wavelength of 940 nm, will be applied over the full extent of the wound. Receives: Device: Light emitting diodes (LED) |
| Fixed diphasic current group (G-DF) | Experimental | The electrical stimulation will be carried out with the fixed diphasic current of the Dualpex 071 equipment, being applied throughout the extension of the wound. Receives: Device: Fixed diphasic current |
| Control group (G-C) | No intervention | Volunteers from this group will not be submitted to treatment and will only be evaluated before, every 30 days, after the 12 week period and 30 days after the last evaluation. It is worth mentioning that, after the end of its participation, if the wound is not fully healed, the treatment will be offered with LED or diphasic current. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ulcer healing - Digital photography
Percentage (%)
Measured: Twelve weeks
Secondary outcomes (6)
Infrared thermography
Skin temperature (Celsius Degree)
Measured: Twelve weeks
Numerical pain scale
Intensity of pain (numerical scale)
Measured: Twelve weeks
Von frey digital analgesiometer
Quantify the sensitivity
Measured: Twelve weeks
Digital Durometer
Analyze the tissue firmness (Shore)
Measured: Twelve weeks
Infrared Plethysmography
Changes in microvascular blood volume (mL/s)
Measured: Twelve weeks
Bioimpedance
Phase angle (KHz)
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Sep 2017 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2021 (estimated)
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 UlcerStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Model description
- Volunteers will also be randomized between groups: * LED treatment group 620 nm (G-LED 620; n = 13) * Treatment group with LED 940 nm (G-LED 940; n = 13) * Treatment group with fixed diphasic current (G-DF; n = 13) * Control group (G-C; n = 13)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
- Investigators
- Rinaldo Guirro, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250533
- Sponsor's protocol ID
- U1111-1143-0079
- Status last verified
- Aug 2017
- First submitted
- 10 Aug 2017
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Borges NCS, Soares LR, Perissini MM, Carvalho MS, Guirro ECO, Freitas MCF, Guirro RRJ. Photobiomodulation using red and infrared spectrum light emitting-diode (LED) for the healing of diabetic foot ulcers: a controlled randomized clinical trial. Lasers Med Sci. 2024 Oct 9;39(1):253. doi: 10.1007/s10103-024-04199-5.
PubMed 39382587
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Effects of Phototherapy With Light-emitting Diodes (LED) and Electrical Stimulation in the Healing of Ulcers of Lower Diabetic Limbs: a Blind Controlled Randomized Clinical Test
- ClinicalTrials.gov ID
- NCT03250533
- Acronym / sponsor ID
- U1111-1143-0079
- Conditions
- Ulcer, Diabetes Mellitus
- Keywords
- Wound healing, Phototherapy, Electrotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 15 Aug 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.
One of the important complications of DM is the diabetic foot that may present ulcers, which result from multiple risk factors, being diabetic peripheral neuropathy and ischemia due to peripheral vascular disease considered the main causes. In this way, the ulcers of the lower extremities of diabetics, have a complex and long cicatrization process. Faced with this, the treatment of chronic wounds is challenging, the diversity of treatments is great, however the search for new modalities of effective therapeutic resources, scientifically proven and financially feasible, that are available and easily accessible for clinical practice is still desirable . The aim of this study was to evaluate the responses of phototherapy with light emitting diodes (LED) and electrical stimulation with the fixed diphasic current (DF) in ulcers of diabetic patients. Diabetic volunteers who present with chronic skin ulcers will also be randomized (n = 13) to: Treatment group with LED 620 nm, Treatment group with LED 940 nm, Treatment group with fixed diphasic current and Control group. Interventions will occur three times a week for 12 weeks and evaluations will occur on the 1st, 30th, 60th, and 90th day of the intervention, followed by follow-up after 30 days of treatment completion.
Detailed description
Background: Diabetes mellitus (DM) is a chronic disease currently considered a worldwide epidemic and has become a major public health problem. One of the important complications of DM is the diabetic foot that may present ulcers, which result from multiple risk factors, being diabetic peripheral neuropathy and ischemia due to peripheral vascular disease considered the main causes. In this way, the ulcers of the lower extremities of diabetics, have a complex and long healing process, as they present a reduction in the angiogenic response and deficiency of growth factors, making difficult the action of conventional treatments. The treatment of chronic wounds is challenging, the diversity of treatments is great, however the search for new modalities of effective, scientifically proven and financially viable therapeutic resources that are available and readily accessible to clinical practice is still desirable. Objective: To evaluate the responses of phototherapy with light emitting diodes (LED) and electrical stimulation with the fixed diphasic current (DF) in diabetic patient ulcers. METHODS: Diabetic volunteers of both genders, aged 30 to 65 years, who present chronic skin ulcers grade I or II will also be randomized (n = 13) in: Treatment group with LED 620 nm (G-LED 620) , Treatment group with LED 940 nm (G-LED 940), Treatment group with fixed diphasic current (G-DF) and Control group (GC). Interventions will occur three times a week for 12 weeks. The evaluations will take place on the pre-intervention day 1, 30, 60 and 90 days, followed by follow-up after 30 days of the end of the treatment, through the following instruments: numerical scale of pain, digital photography, infrared thermography, digital analgesimeter, Digital durometer, infrared plethysmography and bioimpedance. Statistical analysis: To analyze the data, normality test will be used to verify the distribution of the data and adequate statistical test for the appropriate inter- and intragroup comparisons, being thus considered two factors in the comparisons, time and group. A significance level of 5% will be adopted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Volunteers will also be randomized between groups: * LED treatment group 620 nm (G-LED 620; n = 13) * Treatment group with LED 940 nm (G-LED 940; n = 13) * Treatment group with fixed diphasic current (G-DF; n = 13) * Control group (G-C; n = 13)
| Arm | Type | Receives |
|---|---|---|
| LED 620 nm group (G-LED 620) | Experimental | Device: Light emitting diodes (LED)The LED device in the red light spectrum, with a wavelength of 620 nm, will be applied over the full extent of the wound. |
| LED 940 nm group (G-LED 940) | Experimental | Device: Light emitting diodes (LED)The LED device in the infrared light spectrum, with a wavelength of 940 nm, will be applied over the full extent of the wound. |
| Fixed diphasic current group (G-DF) | Experimental | Device: Fixed diphasic currentThe electrical stimulation will be carried out with the fixed diphasic current of the Dualpex 071 equipment, being applied throughout the extension of the wound. |
| Control group (G-C) | No intervention | –Volunteers from this group will not be submitted to treatment and will only be evaluated before, every 30 days, after the 12 week period and 30 days after the last evaluation. It is worth mentioning that, after the end of its participation, if the wound is not fully healed, the treatment will be offered with LED or diphasic current. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age range from 30 to 65 years;
- Diabetic patients with neuropathic, ischemic or neuroischemic ulcers in the legs and / or feet;
- With a duration of 4 weeks or more;
- Being grade I and / or II lesions by the Meggitt-Wagner classification;
- Have a good degree of cognition evaluated by the Mini-Mental State Examination - MEEM (Brucki et al., 2003);
Key exclusion criteria (6 listed)
- Those presenting with an associated disease, such as renal, neurological, immunological, hematological or hepatic disease, which may interfere with evaluation and / or therapeutic procedures, and which are not related to diabetes;
- Malignancies (carcinomas);
- Use of medications that alter the healing process (corticosteroids, immunosuppressants, among others);
- Clinical signs of infection (sepsis), acute cellulitis, osteomyelitis or gangrene;
- Those who do not agree to sign the Free and Informed Consent Form;
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 |
|---|---|---|
| Light emitting diodes (LED)The light-emitting diode (LED) device consists of a soft 15 x 15 cm blanket, which allows the body segment curvature of the cutaneous lesion to be monitored. The LEDs are fixed equidistant to obtain uniform irradiation over the entire ulcer. The wound site will be surrounded by a PVC film (polyvinyl chloride), to avoid contamination, for posterior positioning of the LED device, applying light directly and perpendicularly, with energy density of 6 J / cm². All LEDs will be calibrated prior to the start of applications in the Laboratory of Photobiophysics of the Faculty of Sciences and Letters of Ribeirão Preto, University of São Paulo, in which the wavelengths will be checked, the angle of radiation, power and power density. | Device | LED 620 nm group (G-LED 620), LED 940 nm group (G-LED 940) |
| Fixed diphasic currentThe electrical stimulation treatment will be performed with the fixed diphasic current of the Dualpex 071 equipment (Quark®, Piracicaba, SP, Brazil), with the monopolar technique, 100 Hz, maximum intensity of 1 mA / cm² of lesion for 10 minutes. Autoclave sterilized aluminum electrodes will be used, one on the lesion (negative pole) and the other transversal to the segment (positive pole). The size of the electrode will be proportional to the extension of the lesion, having as a means of contact between the electrode and the ulcer, sterile gauze moistened with 0.9% saline solution. | Device | Fixed diphasic current group (G-DF) |
Primary outcome
Rate of ulcer healing - Digital photography
Time frame: Twelve weeks
Percentage (%)
6 secondary outcomes
Infrared thermography
Time frame: Twelve weeks
Numerical pain scale
Time frame: Twelve weeks
Von frey digital analgesiometer
Time frame: Twelve weeks
Digital Durometer
Time frame: Twelve weeks
Infrared Plethysmography
Time frame: Twelve weeks
Bioimpedance
Time frame: Twelve weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Derived from this study: PubMed 39382587Borges NCS, Soares LR, Perissini MM, Carvalho MS, Guirro ECO, Freitas MCF, Guirro RRJ. Photobiomodulation using red and infrared spectrum light emitting-diode (LED) for the healing of diabetic foot ulcers: a controlled randomized clinical trial. Lasers Med Sci. 2024 Oct 9;39(1):253. doi: 10.1007/s10103-024-04199-5.
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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.
Rinaldo Guirro, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light emitting diodes (LED) and Fixed diphasic current in people with Ulcer and Diabetes Mellitus, run by University of Sao Paulo 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 6 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: status not confirmed, as of the sponsor's last update on 21 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rinaldo Guirro, PhD (+551633154584, rguirro@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ulcer healing - Digital photography (time frame: Twelve 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 NCT03250533, 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 21 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.