Diabetic Foot, Wound Heal
Conditions
Keywords
650 nm laser, infrared laser, chronic diabetic foot ulcer, wound surface area
Brief summary
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
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
Interventions
DEVICElaser therapy
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: 1. 980 nm for wound decontamination, improve circulation, lymphatic drainage 2. 915 nm enhances O2 delivery 3. 810 nm increases ATP production 4. 650 nm accelerate surface healing, tissue regeneration plus traditional wound treatment mentioned before
Sponsors
Heidy F. Ahmed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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
Intervention 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
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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
1. Patients with vascular disease 2. Patients with fixed ankle deformity as Charcot foot or stiffness 3. Patients with any type of osteomyelitis associated with DFU 4. Patients with renal or hepatic failure 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percent of wound size measurement methods | two consecutive months | weekly by 1. a ruler (wound area was calculated by measuring and multiplying the greatest length by the greatest width perpendicular to the greatest length) 2. a sterile transparent film sheet |
| percent of wounds complete closure | two consecutive months | measure percent of wounds complete closure in each group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percent of each type of wound cause | two consecutive months | different wound cause diabetic foot ulcers and healing time |
| percent of each wound location | two consecutive months | different wound location in diabetic foot ulcers and healing time |
| percent of days needed for surface area reduction | two consecutive months | measure the days needed to decrease surface area in each group |
Countries
Egypt
Outcome results
None listed