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

NCT ID: NCT06703762

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-26
• Study Completion Date: 2025-02-01

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.

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.

Conditions

Neuropathic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

He-Ne low level laser (LLL)

Intervention Type: 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

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

Conventional traditional treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Mahmoud Abd Allah Abd Alsadek

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal Mohamed Abd El-baky, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Locations

Cairo University

Giza, , Egypt

Countries

Egypt

Central Contacts

Fatma Mahmoud Abd Allah Abd Alsadek, M.Sc

Role: CONTACT

fatmaabdalsadek36@gmail.com

01006400237

Hussein Gamal Hussein Mogahed, PhD

Role: CONTACT

Facility Contacts

Fatma Mahmoud Abd Allah Abd Alsadek, M.Sc

Role: primary

fatmaabdalsadek36@gmail.com

01006400237

Other Identifiers

P.T.REC/012/005252

Identifier Type: -

Identifier Source: org_study_id