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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Neuropathic Foot Ulcer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06703762

P.T.REC/012/005252

Details and patient eligibility

About

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

Full 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.

Enrollment: 68 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

68 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Conventional traditional treatment

Other: He-Ne low level laser (LLL)

Conventional traditional treatment

Active Comparator group

Description:

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).

Treatment:

Other: Conventional traditional treatment