Clinical trial NCT06703762: Efficacy of Photobiomodulation on Wound Healing and Il-6 in Neuropathic Foot Ulcer
Official title: Efficacy of Photobiomodulation on Wound Healing and Il-6 in Neuropathic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neuropathic Foot Ulcer
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 68
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Measurement of Ulcer Length
timeFrame: 4 weeks
measure: Measurement of Ulcer Width
timeFrame: 4 weeks
measure: Measurement of Ulcer Area
timeFrame: 4 weeks
measure: Measurement of volume of the ulcer
timeFrame: 4 weeks
measure: Assessment of serum IL-6 level
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Professor, Cairo university
name: Amal Mohamed Abd El-baky, PhD
role: STUDY_CHAIR
References: