The Effect of Combined 650 nm and Infrared Laser on Chronic Diabetic Foot Ulcer Surface Area:

Study Overview
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Brief Summary
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Objective: investigate the effect of combined 650 nm and infrared laser on chronic diabetic foot ulcer surface area. 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

Detailed Description
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Objective: investigate the effect of combined 650 nm and infrared laser on chronic diabetic foot ulcer surface area. 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 days needed for surface area reduction before and after receiving the treatment protocol for two consequetive months, and the secondary outcomes were % of wound cause and location frequencies

Official Title
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The Effect of Combined 650 nm and Infrared Laser on Chronic Diabetic Foot Ulcer Surface Area: a Randomized Controlled Trial

Conditions
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Diabetic Foot, Wound Heal

Intervention / Treatment
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* Device: laser therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1- Diabetic patients with either type I or II 2- Age from 18-60 years old, both sexes 3- Ulcer lasting longer than two months 4- DFU grade 1 or 2 according to Wagner classification. 5- All patients able to walk dependently Exclusion Criteria: Patients with vascular disease Patients with fixed ankle deformity as Charcot foot or stiffness Patients with any type of osteomyelitis associated with DFU Patients with renal or hepatic failure BMI < 30 kg/m2 as Obesity can cause poor perfusion due to vascular insufficiencies; altered population of immune mediators may lengthen the inflammatory process & decrease oxygenation of subcutaneous adipose tissue which is liable to be infected.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laser sequential mode<br>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 | Device: laser therapy<br>* All patients received 2 sessions of laser therapy / week in two consecutive months of treatment aiming complete wound closure , patients received & infrared laser therapy plus traditional wound care: (I) Use red & infrared laser therapy device with 4 different wavelengths in a synchronized mode: 980 nm for wound decontamination, improve circulation, lymphatic drainage 915 nm enhances O2 delivery 810 nm increases ATP production 650 nm accelerate surface healing, tissue regeneration plus traditional wound treatment mentioned before<br>|
| Experimental: laser seperate mode<br>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 | Device: laser therapy<br>* All patients received 2 sessions of laser therapy / week in two consecutive months of treatment aiming complete wound closure , patients received & infrared laser therapy plus traditional wound care: (I) Use red & infrared laser therapy device with 4 different wavelengths in a synchronized mode: 980 nm for wound decontamination, improve circulation, lymphatic drainage 915 nm enhances O2 delivery 810 nm increases ATP production 650 nm accelerate surface healing, tissue regeneration plus traditional wound treatment mentioned before<br>|
| Active Comparator: traditional wound care<br>(II) 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 | Device: laser therapy<br>* All patients received 2 sessions of laser therapy / week in two consecutive months of treatment aiming complete wound closure , patients received & infrared laser therapy plus traditional wound care: (I) Use red & infrared laser therapy device with 4 different wavelengths in a synchronized mode: 980 nm for wound decontamination, improve circulation, lymphatic drainage 915 nm enhances O2 delivery 810 nm increases ATP production 650 nm accelerate surface healing, tissue regeneration plus traditional wound treatment mentioned before<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of wound size measurement methods | weekly by a ruler (wound area was calculated by measuring and multiplying the greatest length by the greatest width perpendicular to the greatest length) a sterile transparent film sheet | two consecutive months | 
| percent of wounds complete closure | measure percent of wounds complete closure in each group | two consecutive months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of each type of wound cause | different wound cause diabetic foot ulcers and healing time | two consecutive months | 
| percent of each wound location | different wound location in diabetic foot ulcers and healing time | two consecutive months | 
| percent of days needed for surface area reduction | measure the days needed to decrease surface area in each group | two consecutive months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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650 nm laser, infrared laser, chronic diabetic foot ulcer, wound surface area