Efficacy of Photobiomodulation on Wound Healing and Il-6 in Neuropathic Foot Ulcer

Condition(s) studied

Investigational drug(s) / intervention(s)

He-Ne low level laser (LLL): Patients in the experimental group will receive treatment with LLLT. The ulcer bed will be irradiated locally with red light (660 nm). The ulcer size and its depth will be used as the basis to calculate the duration of exposure needed to deliver 3-10 J/cm² for 15 to 20 minutes. The application will take place in 3 sessions per week for 4 weeks. Each patient will be asked to lie in a supine position with the ulcer easily exposed to the laser beam, and they will be instructed to wear laser glasses and avoid looking directly at the beam until the end of the session.

Conventional traditional treatment: All patients in both the groups will receive the required, conventional treatments of diabetic wound care, including dressing, antibiotics, controlling diabetes, cholesterol, and blood pressure along with aggressive drug treatment and wound debridement when needed.

Study summary

The aim of this study is to detect the effect of Laser Photobiomodualation on the wound healing and Il-6 in neuropathic foot ulcer.

Eligibility

Primary outcome measure(s)

• Measurement of Ulcer Length — 4 weeks
  The length of the ulcer can be precisely measured using the Imito Measure application. By utilizing a specialized marker for calibration, the app allows users to trace the ulcer's longest dimension. After capturing an image, the app calculates the length automatically, providing an accurate measurement.
• Measurement of Ulcer Width — 4 weeks
  The width of the ulcer is measured in a similar manner using the Imito Measure app. Users trace the widest part of the wound, and the app, after calibration with the marker, determines the exact width from the captured photo.
• Measurement of Ulcer Area — 4 weeks
  The area of the ulcer is calculated by encircling the entire wound boundary using the Imito Measure application. The app uses the calibration marker to ensure accuracy and then automatically computes the total wound area. The Imito Measure application has been scientifically validated as a reliable alternative to traditional wound measurement methods, such as wound rulers.
• Measurement of volume of the ulcer — 4 weeks
  It can be measured by using Syringe method by injecting saline into the wound until it overflows from the wound and measure the amount of saline.
• Assessment of serum IL-6 level — 4 weeks
  Samples of venous blood from the cubital vein will be taken from each patient. Collected blood samples will be transferred into a test tube pre-fabricated with an anticoagulant. The blood samples will remain in the test tubes for about 30 minutes and will then be distributed to a biochemical laboratory, where they will be centrifuged at 6,000 rpm for 10 minutes. The serum will be separated from the test tube and transferred to an Eppendorf tube. All serum samples will be stored at -80°C until complete analysis and measurement of IL-6 levels. The IL-6 level in the serum will then be determined. Additionally, fasting blood sugar levels will be measured to assess the stabilization of the condition.

Trial sites (1)

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