Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer

Study Overview
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Brief Summary
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Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer

Detailed Description
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Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer both sexes were included and intervention will be given for two months, wound healing will be assessed by measuring the surface area and the Aerobic microflora will be isolated and controlled on the basis of bio-gram and antibiogram at the beginning and at the end of treatment.

Official Title
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Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer

Conditions
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Wound Healing Disorder

Intervention / Treatment
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* Radiation: polarized light
* Other: Medical Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients with diagnosed diabetic foot ulcer lasting at least 4 weeks ( sized from 0.5 to 2 cm Cooperative and mentally stable patients . Exclusion Criteria: Hepatic patients . Uncontrolled hypertension . Uncontrolled diabetic patients with HbA1c>8.5% . Neurological disorders . Musculoskeletal disorders that interfere with program . Previous history or any sign of DVT .

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bioptron light therapy and medical care<br>bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks plus medical care in the form of Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results | Radiation: polarized light<br>* bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks<br>* Other names: bioptron light therapy;|
| Active Comparator: medical care<br>Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results | Other: Medical Care<br>* Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic evaluation: | Aerobic microflora will be isolated and controlled on the basis of biogram and antibiogram at the beginning and at the end of treatment | two months | 
| Wound assessment | The wound surface area (ulcer size), lenghth and width will measured using Ruler technique | two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, foot ulcer, polarized light, ;wound healing