An interventional study of Red Light-emitting diode device and Infrared Light-emitting diode device in Diabetic Neuropathies, sponsored by Rinaldo Roberto de Jesus Guirro. Completed at 1 site in Brazil. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-03-13.
Sponsored by Rinaldo Roberto de Jesus Guirro · Not applicable, Interventional, and Treatment
Among 16 studies in Diabetic Neuropathies with a site in Brazil — 1 open to participants now, 1 under way, 1 of them phase 3. Diabetic Neuropathies · Brazil.
Among the 16 studies in Diabetic Neuropathies with a site in Brazil, this one is the 8th largest by enrollment of the 15 interventional ones that give a count, is one of 2 that started in 2018, is one of 6 with no phase, and was the 9th registered.
538 studies on the registry are indexed under Diabetic Neuropathies; 80 are open to participants now.
Browse Diabetic Neuropathies studies →1 of the 16 studies in Diabetic Neuropathies with a site in Brazil is open now. Recruiting first, the newest first:
Brainfarma Industria Química e Farmacêutica S/A · Sites in Brazil
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 52 Diabetic Neuropathies studies recruiting now, 21 (40%) set no upper age limit and 24 (46%) stop at 75 or younger; 6 take children under 18; 3 take healthy volunteers.
This study: 45 Years to 70 Years · all sexes · no healthy volunteers.
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16 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 2 started in 2018.
This study's enrollment of 65 is close to the median of 68 across 448 interventional studies indexed under Diabetic Neuropathies.
Median enrollment 65 across the 15 interventional studies, 80 across the 1 observational. Of the 13 that completed or were terminated, 3 (23%) have results posted.
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4 of 16 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Rinaldo Roberto de Jesus Guirro as lead sponsor.
Rinaldo Roberto de Jesus Guirro has 1 study filed under Diabetic Neuropathies — fewer than ten, so there is no comparison to draw.
1 of the studies in Diabetic Neuropathies with a site in Brazil that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07712913Phase 3Brainfarma Industria Química e Farmacêutica S/AExtended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia | 2027-06-01 |
Among the 16 studies in Diabetic Neuropathies with a site in Brazil, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Diabetes mellitus (DM) is a metabolic disorder, characterized by hyperglycemia and metabolic disorders, resulting in changes in insulin secretion and / or action. Physical function is critical for functional independence, and chronic diseases such as diabetes can lead to functional decline, and diabetes mellitus is a major contributor to the progression of sarcopenia and physical disability. DM is also known to have a strong associated with the development of peripheral arterial disease. Peripheral arterial disease is characterized by obstruction of the arteries of the lower limbs, leading to a low oxygenation of the muscles of the lower extremities. Among the physiotherapeutic resources that can be used, phototherapy involves the use of light for the treatment of muscular injuries, by modulating the physiological processes associated with the repair process. Clinical trials show that light emitting diode (LED) is a technique that interferes with muscle strength, generating an increase in maximal voluntary contraction and peak torque. It is hypothesized that the LED application is capable of improving the muscular strength, fatigue, functional performance and blood flow capabilities in individuals with diabetes. It is also expected that the results of this study may contribute to and increase the resources used by physiotherapists within the clinical scope, contributing to the care of diabetic patients.
Diabetes mellitus (DM) is a metabolic disorder, characterized by hyperglycemia and metabolic disorders, resulting in changes in insulin secretion and / or action. Physical function is critical for functional independence, and chronic diseases such as diabetes can lead to functional decline, and diabetes mellitus is a major contributor to the progression of sarcopenia and physical disability. DM is also known to have a strong associated with the development of peripheral arterial disease. Peripheral arterial disease is characterized by obstruction of the arteries of the lower limbs, leading to a low oxygenation of the muscles of the lower extremities. Among the physiotherapeutic resources that can be used, phototherapy involves the use of light for the treatment of muscular injuries, by modulating the physiological processes associated with the repair process. Clinical trials show that LED is a technique that interferes with muscle strength, generating an increase in maximal voluntary contraction and peak torque. It is hypothesized that the LED application is capable of improving the muscular strength, fatigue, functional performance and blood flow capabilities in individuals with diabetes. It is also expected that the results of this study may contribute to and increase the resources used by physiotherapists within the clinical scope, contributing to the care of diabetic patients. A randomized and blinded clinical trial will be carried out at the Physiotherapeutic Resources Laboratory (LARF) of the University of São Paulo Medical School of Ribeirão Preto (FMRP-USP). The study procedures will be performed in 5 days. On the first day (pre-treatment), the volunteers will be evaluated for functionality (Time Up and Go), cardiopulmonary capacity (6-minute walk test), evaluation of muscle function (isokinetic dynamometer), neuromuscular recruitment (electromyography) gastrocnemius and evaluation of blood flow (Doppler) of the tibial and popliteal arteries. On the second, third and fourth day volunteers of GLED-V, GLED-IV, GM e GP will return to the application of LED intervention according to the group in which they are allocated. On the fifth day (reevaluation) the volunteers will perform the same tests of the first day.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
the volunteers of this group will not be submitted to the intervention.
in the volunteers of this group will be applied Red Light-emitting diode device with the length 620nm wave along the entire tibialis anterior muscle and bilateral sural triceps.
Device: Red Light-emitting diode device
in the volunteers of this group will be applied Infrared Light-emitting diode device with the wavelength of 940nm throughout the tibialis anterior muscle and bilateral sural triceps.
Device: Infrared Light-emitting diode device
in the volunteers of this group will be applied Infrared and Red Light-emitting diode device with the wavelength of 940nm and 620nm throughout the tibialis anterior muscle and bilateral sural triceps.
Device: Infrared and Red Light-emitting diode device
LED device off.
Device: Sham
The phototherapy will be applied for 3 days followed by a red LED blanket of 25x40 cm2, with equidistant distribution - 1 cm between them, with total energy per area of 180 J, bilaterally on the anterior tibial and triceps sural muscles, bilaterally. The intervention of these muscular groups is made possible by the distal involvement of diabetic polyneuropathy. All LEDs will be checked at the beginning of the project in the Laboratory of Photophysics of the Faculty of Philosophy, 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.
The phototherapy will be applied for 3 days followed by a infrared LED blanket of 25x40 cm2, with equidistant distribution - 1 cm between them, with total energy per area of 180 J, bilaterally on the anterior tibial and triceps sural muscles, bilaterally. The intervention of these muscular groups is made possible by the distal involvement of diabetic polyneuropathy. All LEDs will be checked at the beginning of the project in the Laboratory of Photophysics of the Faculty of Philosophy, 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.
The phototherapy will be applied for 3 days followed by a infrared and Red LED blanket of 25x40 cm2, with equidistant distribution - 1 cm between them, with total energy per area of 180 J, bilaterally on the anterior tibial and triceps sural muscles, bilaterally. The intervention of these muscular groups is made possible by the distal involvement of diabetic polyneuropathy. All LEDs will be checked at the beginning of the project in the Laboratory of Photophysics of the Faculty of Philosophy, 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.
LED device off.
strength capacities
N/m
Time frame: Twenty minutes
Electromyography
Muscle recruitment - Hertz
Time frame: Twenty minutes
Time up and Go
time
Time frame: two minutes
6-minute walk test
meters
Time frame: ten minutes
blood flow
mL/s
Time frame: ten minutes
Plan to share: Undecided
Ran from Feb 2018 to primary completion in Jul 2019, 17 months.
Of 137 non-industry interventional studies with no phase under Diabetic Neuropathies, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's 17 months is above that.
Counting every sponsor, half of 152 studies reached it within 12 months; a quarter within 6 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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