Effect of laser on Diabetic Foot: randomized clinical trial

INTERVENTION: E07.632.490 Participants will be followed up for 12 weeks, attending the outpatient consultation once a week, where biological material will be collected at the first consultation (T0), at the fifth consultation (T4), at the ninth consultation (T8) and at the thirteenth consultation ( T12). In all consultations, the wound will be photographed and cleaned with saline solution, debridement if necessary and treatment applied. In the intervention group, photobiomodulation (laser) will be applied once a week + hydrogel on the wound. In the control group, hydrogel will be applied to the wound. Participants will be instructed to perform the dressing every day at home, applying the hydrogel as a primary dressing, in which the hydrogel will be made available free of charge to all participants in both groups. The secondary dressing will be oriented to change whenever wet. Participants will be allocated to groups by randomization (draw), with 41 for the intervention group and 41 for the control group. All participants will have a diagnosis of diabetes mellitus. CONDITION: C18.452.394.750 Diabetic Foot PRIMARY OUTCOME: Change in wound area size from initiation of treatment to end of follow‐up period, 12 weeks. The difference in the area of the wound will be evaluated through the weekly photographs, the photos will be inserted in the ImageJ software that calculates the area in square centimeters. SECONDARY OUTCOME: Analysis of the expression of inflammatory cytokines using the polymerase chain reaction (PCR) technique and enzyme‐linked immunosorbent assay (ELISA) The appearance of tissue quality in the wound bed (granulation tissue), decrease in exudate, appearance and contraction of edges will be assessed using the Bates‐Jansen Wound Assessment Tool. Wound area reduction will be measured in square centimeters (cm2), length Xwidth of the area will be measured in cm2 and area change calculated in percentage (%). Wound closure will be expressed in %, calculated by the following mathematical formula, called the ulcer contraction inde X(ICU): ; ; ICU= Initial wound area‐ (Daily area)(Initial area) X100% ; INCLUSION CRITERIA: Participants with diabetes mellitus; both genders; aged 18 or over; foot wound