Effect of Photobiomodulation as a Preventive Treatment for Diabetic Foot

The incidence of foot ulcers will be assessed through clinical examination. In addition to these in-person assessments, participants will be monitored daily via telephone contact, during which the researchers (resident physicians) will inquire about any changes in the skin, discomfort, and the use of PBM equipment.

The incidence of foot ulcers will be assessed through clinical examination. In addition to these in-person assessments, participants will be monitored daily via telephone contact, during which the researchers (resident physicians) will inquire about any changes in the skin, discomfort, and the use of PBM equipment.

The incidence of foot ulcers will be assessed through clinical examination. In addition to these in-person assessments, participants will be monitored daily via telephone contact, during which the researchers (resident physicians) will inquire about any changes in the skin, discomfort, and the use of PBM equipment.

This assessment will be conducted using the Semmes-Weinstein esthesiometer 5.07 with a 10 g filament, following the standard technique outlined in the IWGDF 2019 guidelines, as described in Annex 1. The test will be performed at three different locations on both feet. Protective sensation will be considered present if the patient responds correctly in two out of three applications at each location, and absent if they respond incorrectly in two out of three applications. Each esthesiometer will be used to evaluate a maximum of 10 participants on the same day and discarded after 70 evaluations to maintain accuracy.

This assessment will be conducted using the Semmes-Weinstein esthesiometer 5.07 with a 10 g filament, following the standard technique outlined in the IWGDF 2019 guidelines, as described in Annex 1. The test will be performed at three different locations on both feet. Protective sensation will be considered present if the patient responds correctly in two out of three applications at each location, and absent if they respond incorrectly in two out of three applications. Each esthesiometer will be used to evaluate a maximum of 10 participants on the same day and discarded after 70 evaluations to maintain accuracy.

Participants will be tested with a 128 Hz tuning fork applied to the dorsal aspect of the distal phalanx of the first toe (hallux) or another toe if the hallux is absent. The test will be considered positive if the participant responds correctly to at least two out of three applications and negative if two out of three responses are incorrect

Participants will be tested with a 128 Hz tuning fork applied to the dorsal aspect of the distal phalanx of the first toe (hallux) or another toe if the hallux is absent. The test will be considered positive if the participant responds correctly to at least two out of three applications and negative if two out of three responses are incorrect

The assessment of the Achilles reflex will be conducted with the participant seated, with the foot relaxed and suspended in slight dorsiflexion. A gentle tap will be applied with a reflex hammer to the Achilles tendon. The result will be considered abnormal if plantar flexion reflex of the foot is not observed. The loss of the Achilles tendon reflex is associated with diabetic neuropathy

The assessment of the Achilles reflex will be conducted with the participant seated, with the foot relaxed and suspended in slight dorsiflexion. A gentle tap will be applied with a reflex hammer to the Achilles tendon. The result will be considered abnormal if plantar flexion reflex of the foot is not observed. The loss of the Achilles tendon reflex is associated with diabetic neuropathy

For the calculation of ESN, patients will be asked about: the sensation of pain or discomfort in the legs and the occurrence, location, timing, and relief of symptoms such as fatigue, cramps, itching, burning, numbness, and tingling in the lower limb. PN will be considered mild when ESN scores between 3 and 4, moderate when between 5 and 6, or severe when reaching 7 to 9 points.

For the calculation of ESN, patients will be asked about: the sensation of pain or discomfort in the legs and the occurrence, location, timing, and relief of symptoms such as fatigue, cramps, itching, burning, numbness, and tingling in the lower limbs. PN will be considered mild when ESN scores between 3 and 4, moderate when between 5 and 6, or severe when reaching 7 to 9 points.

Painful sensitivity will be assessed by applying pressure for 1 second with a blunt-tipped pin on the dorsal surface of the skin near the hallux nail, and thermal sensitivity will be assessed using a metal rod cooled to 32 and 36°C applied at the same location.

Before the tests, procedures will be demonstrated on the hands. Sensitivities will be scored on each foot as present (0 points) or reduced/absent (1 point). The reflex will be scored as normal (0 points), present with effort (1 point), or absent (2 points). ECN ranges from 0 to 10, obtained by summing the scores of both feet. Values between 3 and 5 indicate mild neuropathy signs, between 6-8 indicate moderate neuropathy signs, and between 9 and 10 indicate severe neuropathy signs

Painful sensitivity will be assessed by applying pressure for 1 second with a blunt-tipped pin on the dorsal surface of the skin near the hallux nail, and thermal sensitivity will be assessed using a metal rod cooled to 32 and 36°C applied at the same location.

Before the tests, procedures will be demonstrated on the hands. Sensitivities will be scored on each foot as present (0 points) or reduced/absent (1 point). The reflex will be scored as normal (0 points), present with effort (1 point), or absent (2 points). ECN ranges from 0 to 10, obtained by summing the scores of both feet. Values between 3 and 5 indicate mild neuropathy signs, between 6-8 indicate moderate neuropathy signs, and between 9 and 10 indicate severe neuropathy signs

The ankle-brachial index (ABI) will be measured by placing the sphygmomanometer cuff in the usual manner on the UL (above the elbow crease) and just above the ankle bones (ankle) on the LL with the patient in a supine position; inflating the cuff until the sound of blood flow becomes inaudible and then deflating it until the first sound of blood flow is heard, which corresponds to the maximum systolic pressure. Measurements will be repeated three times.

The ankle-brachial index (ABI) will be measured by placing the sphygmomanometer cuff in the usual manner on the UL (above the elbow crease) and just above the ankle bones (ankle) on the LL with the patient in a supine position; inflating the cuff until the sound of blood flow becomes inaudible and then deflating it until the first sound of blood flow is heard, which corresponds to the maximum systolic pressure. Measurements will be repeated three times.

In the distal segments of the anterior and posterior tibial arteries and fibular artery in cm²/s measured by Doppler ultrasound.

In the distal segments of the anterior and posterior tibial arteries and fibular artery in cm²/s measured by Doppler ultrasound.

In the distal segments of the anterior and posterior tibial arteries and fibular artery - calculated by the formula (systolic peak velocity - diastolic peak velocity) / systolic peak velocity.

In the distal segments of the anterior and posterior tibial arteries and fibular artery - calculated by the formula (systolic peak velocity - diastolic peak velocity) / systolic peak velocity.

The waveform pattern of the distal segments of the anterior and posterior tibial arteries and fibular artery in Doppler ultrasound examination will be classified as triphasic, biphasic, or monophasic.

The waveform pattern of the distal segments of the anterior and posterior tibial arteries and fibular artery in Doppler ultrasound examination will be classified as triphasic, biphasic, or monophasic.

The accuracy of using the Edinburgh Claudication Questionnaire alone is debatable, but this instrument can be used as a complement to clinical evaluation data for PAD. The questionnaire consists of 6 questions and has been validated for Portuguese. The definition of positive claudication requires the following set of responses: 1 = "yes", 2 = "no", 3 = "yes", 5 = "usually disappears in 10 minutes or less", and 6 = "calf" and/or "thigh" and/or "buttock" (regardless of whether other locations are marked) or NEGATIVE if any different combination is marked. Question 4 is not used to define the presence but rather the severity of claudication: "No" = Grade 1 (mild severity); and "Yes" = Grade 2.

The accuracy of using the Edinburgh Claudication Questionnaire alone is debatable, but this instrument can be used as a complement to clinical evaluation data for PAD. The questionnaire consists of 6 questions and has been validated for Portuguese. The definition of positive claudication requires the following set of responses: 1 = "yes", 2 = "no", 3 = "yes", 5 = "usually disappears in 10 minutes or less", and 6 = "calf" and/or "thigh" and/or "buttock" (regardless of whether other locations are marked) or NEGATIVE if any different combination is marked. Question 4 is not used to define the presence but rather the severity of claudication: "No" = Grade 1 (mild severity); and "Yes" = Grade 2.

. To utilize this technique, the imaging room should be climate-controlled with a stabilized temperature between 21 and 23°C. After removing shoes and socks, participants will lie in a supine position with a pillow under their legs without ankle support, keeping their legs slightly apart for at least 15 minutes to allow temperature equilibrium and circulation stabilization of the limbs. Participants will be instructed to clean their lower limbs or take a bath at least 2 hours before the examination, avoid physical activity on the day of the examination, and refrain from applying creams or any substances to the lower limbs. Infrared images (thermograms) will be captured by a highly sensitive infrared sensor (18mm, resolution 320x240 pixels), Flir T420®, supported on a tripod maintained at 150 cm from the participants' foot soles, and a 15 cm ruler will be included in each image.

. To utilize this technique, the imaging room should be climate-controlled with a stabilized temperature between 21 and 23°C. After removing shoes and socks, participants will lie in a supine position with a pillow under their legs without ankle support, keeping their legs slightly apart for at least 15 minutes to allow temperature equilibrium and circulation stabilization of the limbs. Participants will be instructed to clean their lower limbs or take a bath at least 2 hours before the examination, avoid physical activity on the day of the examination, and refrain from applying creams or any substances to the lower limbs. Infrared images (thermograms) will be captured by a highly sensitive infrared sensor (18mm, resolution 320x240 pixels), Flir T420®, supported on a tripod maintained at 150 cm from the participants' foot soles, and a 15 cm ruler will be included in each image..

The quality of life of individuals will be assessed using the Diabetes-21 instrument, which is a multidimensional scale adapted from the Diabetes-39, validated for Brazilian Portuguese.

The quality of life of individuals will be assessed using the Diabetes-21 instrument, which is a multidimensional scale adapted from the Diabetes-39, validated for Brazilian Portuguese.