The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- percent of collagen formation
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
the patient didn't know the types of modes of laser applied even in the control group i used light not laser to equalize the blindness
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
laser sequential mode
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
Intervention: laser therapy (Device)
laser seperate mode
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
Intervention: laser therapy (Device)
traditional wound care
Traditional wound care inform of
- Wound care treatment
- Debridement to remove necrotic tissue
- Irrigation of the wound by normal saline
- Change dressing daily to protect wound from infection
- Foot care
- Wash feet daily, dry carefully especially between toe
- Avoid extreme temperatures
- Inspection daily of foot blisters
- Foot wear
- Avoid walking bare foot
- Properly fitted shoes
- Avoid wearing open-toed shoes
Intervention: laser therapy (Device)
Outcomes
Primary Outcomes
percent of collagen formation
Time Frame: two consecutive months
by histological pictures
percent of wound size measurement methods
Time Frame: two consecutive months
measure percent of wounds decrease surface area
Secondary Outcomes
- percent of wounds complete closure(two consecutive months)
Investigators
Heidy F. Ahmed
Doctor of physical therapy certified wound specialist at Al kasr Al Anini teaching hospital, Cairo, Egypt
Cairo University