Efficacy of Photobiomodulation on Wound Healing and Il-6 in Neuropathic Foot Ulcer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hussein Gamal Hussein Mogahed, PhD
Study Contact Backup
- Name: Fatma Mahmoud Abd Allah Abd Alsadek, M.Sc
- Phone Number: 01006400237
- Email: fatmaabdalsadek36@gmail.com
Study Locations
-
-
-
Giza, Egypt
- Cairo University
-
Contact:
- Fatma Mahmoud Abd Allah Abd Alsadek, M.Sc
- Phone Number: 01006400237
- Email: fatmaabdalsadek36@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: He-Ne low level laser (LLL) + Conventional traditional treatment
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.
|
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.
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.
|
|
Active Comparator: Conventional traditional treatment
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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 weeks
|
|
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.
|
4 weeks
|
|
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 weeks
|
|
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.
|
4 weeks
|
|
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.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Amal Mohamed Abd El-baky, PhD, Professor, Cairo University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005252
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.