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

NCT06703762 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005252
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathic Foot Ulcer

Outcome Measures

Primary Outcomes (5)

• Measurement of Ulcer Length

  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.

  4 weeks

• Measurement of Ulcer Width

  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.

  4 weeks

• Measurement of Ulcer Area

  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 weeks

• Measurement of volume of the ulcer

  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.

  4 weeks

• Assessment of serum IL-6 level

  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.

  4 weeks

Study Arms (2)

He-Ne low level laser (LLL) + Conventional traditional treatment

EXPERIMENTAL

It will include 34 patients with chronic neuropathic foot ulcer from both sex. They will receive He-Ne LLL for chronic neuropathic foot ulcer with pulsed wave form, visible ray, wave length of 632.8 nm, peak potency of 30 mW, (Laser -HTM). The application time will be 80 (4 J/cm2) seconds. The application will be 3 sessions /week for 4 weeks on the sole of the foot + Conventional traditional treatment.

Other: He-Ne low level laser (LLL); Other: Conventional traditional treatment

Conventional traditional treatment

ACTIVE COMPARATOR

It will include 34 patients with chronic neuropathic foot ulcer from both sex. They will receive conventional traditional treatment (regular sharp debridement of calluses surrounding the ulcer, use of walking or total-contact casts for off-loading and regular moist dressing patients will be instructed to use only sodium chloride (saline solution 0.9%), regarding the daily asepsis of the ulcer).

Other: Conventional traditional treatment

Interventions

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.

He-Ne low level laser (LLL) + Conventional traditional treatment

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.

Conventional traditional treatment; He-Ne low level laser (LLL) + Conventional traditional treatment

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

Study Officials

• Amal Mohamed Abd El-baky, PhD

  Professor, Cairo university

  STUDY CHAIR

Central Study Contacts

Fatma Mahmoud Abd Allah Abd Alsadek, M.Sc

CONTACT

01006400237; fatmaabdalsadek36@gmail.com

Hussein Gamal Hussein Mogahed, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: November 26, 2024
• Primary Completion: January 26, 2025
• Study Completion: February 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

EG (1)