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NCT Number: NCT06703762

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

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

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Key information

Conditions

Neuropathic Foot Ulcer

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Wound healing is a complex, interactive, and integrative event, involving cellular and chemotactic activity with release of chemical mediators associated with vascular responses and cell proliferation. It consists in a sequence of events leading to the closure of dermal injuries. The repair follows steps of inflammation, re-epithelization, wound contraction, and matrix remodeling. The healing process can be influenced by various local and systemic factors.

The ulcer treatment in the diabetic foot requires a multidisciplinary approach, including revascularization and surgical procedures, as well as the infection treatment, physiotherapeutic rehabilitation with electric phototherapeutic resources to control edema, pain, metabolic disorders, tissue malnutrition, co morbidities, precise treatment of the wound and biomechanics' decompression that will help in amputation prevention.

Biophotomodulation in the form of Low level laser (LLL) irradiation can promote cell migration and cell proliferation by stimulating mitochondrial activity and maintaining viability without causing damage to the wounded cells.

The usage of LLLT presents itself as being a new therapeutic proposal, seeking the cure of these injuries, the improvement on the quality of life of the affected individuals, as well as the reduction of the costs of the treatment in the health system, this study aims to identify the effects of low-level laser therapy on neuropathic foot ulcer healing and the effect of LLL on the hyperglycemic-induced inflammatory response in IL-6 and sought to identify which pathway it might achieve this effect.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patient will be diagnosed with neuropathic foot ulcer.
  • All patient diagnosed as type II Diabetes Mellitus.
  • Wound size a 6-12 cm2.
  • Diabetic ulcers will be in grade 2 and 3 (Partial thickness skin loss involving epidermis and or dermis (superficial, abrasion, blister, and / or full thickness skin loss damage ore necrosis of subcutaneous tissue may extend down to but not through underlying fascia.

Exclusion criteria

  • Presence of osteomyelitis.
  • Patients associated with critical illness who needs intensive care.
  • Patients who suffer from cellulitis.
  • Patients who suffer from nerve injury.
  • Pregnancy.
  • Smokers
  • Malignant diseases
  • Use of immunosuppressive drugs
  • Phenytoin, cyclosporine, calcium channel blockers, etc.
  • Patients who not have burn or ulcer or trauma in this area

Treatment and study plan

He-Ne low level laser (LLL)

Other

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

Other

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.

Primary outcomes

  1. Measurement of Ulcer Length

    Time frame: 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.

  2. Measurement of Ulcer Width

    Time frame: 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.

  3. Measurement of Ulcer Area

    Time frame: 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.

  4. Measurement of volume of the ulcer

    Time frame: 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.

  5. Assessment of serum IL-6 level

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma Mahmoud Abd Allah Abd Alsadek, M.Sc

CONTACT

[email protected]

01006400237

Hussein Gamal Hussein Mogahed, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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