The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer (wounds)

Cairo University (CU)

Status: Completed

Conditions: Diabetic Foot; Collagen Diseases; Wound Heal

Treatments: Device: laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05739214

NILES-EC-CU 23/3/3

Details and patient eligibility

About

Objective: investigate The effect of combined red and infrared lasers on histopathology collagen formation in diabetic foot ulcer Participants: The forty five patients will assigned randomly into three equal groups, each group consist of 15 patients, group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive conventional wound care treatment

Full description

Objective: investigate The effect of combined red and infrared lasers on histopathology collagen formation in diabetic foot ulcer Participants: The forty five patients will assigned randomly into three equal groups, each group consist of 15 patients, group A received laser therapy in sequential mode, group B received laser therapy in separate mode and the control group C receive traditional wound care Outcomes: the primary outcomes were the wound surface area measurement, % of wound complete closure and % of collage formation before and after receiving the treatment protocol for two consequetive months

Enrollment: 45 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• aged between 18 and 60 years; both gender; Diabetic patients type II; Ulcer lasting longer than two months; diabetic foot ulcer (DFU) grade 1 (Superficial diabetic ulcer, ulcer limited to the dermis, not extending to the subcutis) or grade 2 (Ulcer of the skin extending through the subcutis with exposed tendon or bone and without osteomyelitis or abscess formation) according to the Wagner classification

Exclusion criteria

• Patients with fixed ankle deformity as Charcot foot or stiffness; Patients with any type of osteomyelitis associated with DFU; the presence of active infection requiring hospitalization, gangrene, systemic diseases such as collagen-vascular diseases, renal failure, evidence of ischemia; BMI < 30 kg/m2 as Obesity can cause poor perfusion due to vascular insufficiencies; an altered population of immune mediators may lengthen the inflammatory process & decrease oxygenation of subcutaneous adipose tissue which is liable to be infected

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups

laser sequential mode

Experimental group

Description:

All patients received 2 sessions of laser therapy / week with different wavelengths in sequential mode in two consecutive months of treatment aiming complete wound closure , patients received \& infrared laser therapy plus traditional wound care

Treatment:

Device: laser therapy

laser seperate mode

Experimental group

Description:

All patients received 2 sessions of laser therapy / week with different wavelengths in seperate mode in two consecutive months of treatment aiming complete wound closure , patients received \& infrared laser therapy plus traditional wound care

Treatment:

Device: laser therapy

traditional wound care

Active Comparator group

Description:

Traditional wound care inform of 1. Wound care treatment * Debridement to remove necrotic tissue * Irrigation of the wound by normal saline * Change dressing daily to protect wound from infection 2. Foot care * Wash feet daily, dry carefully especially between toe * Avoid extreme temperatures * Inspection daily of foot blisters 3. Foot wear * Avoid walking bare foot * Properly fitted shoes * Avoid wearing open-toed shoes

Treatment:

Device: laser therapy