The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer
- Conditions
- Diabetic FootWound HealCollagen Diseases
- Interventions
- Device: laser therapy
- Registration Number
- NCT05739214
- Lead Sponsor
- Cairo University
- Brief Summary
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
- Detailed 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description laser seperate mode laser therapy 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 traditional wound care laser therapy 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 laser sequential mode laser therapy 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
- Primary Outcome Measures
Name Time Method percent of collagen formation two consecutive months by histological pictures
percent of wound size measurement methods two consecutive months measure percent of wounds decrease surface area
- Secondary Outcome Measures
Name Time Method percent of wounds complete closure two consecutive months measure percent of wounds complete closure in each group
Trial Locations
- Locations (1)
Al Kasr Al Aini Teaching Hospital
🇪🇬Giza, Egypt