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Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer

Primary Purpose

Wound Healing Disorder

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
polarized light
Medical Care
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Healing Disorder focused on measuring diabetes, foot ulcer, polarized light, ;wound healing

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The patients with diagnosed diabetic foot ulcer lasting at least 4 weeks ( sized from 0.5 to 2 cm
  2. Cooperative and mentally stable patients .

Exclusion Criteria:

  1. Hepatic patients .
  2. Uncontrolled hypertension .
  3. Uncontrolled diabetic patients with HbA1c>8.5% .
  4. Neurological disorders .
  5. Musculoskeletal disorders that interfere with program .
  6. Previous history or any sign of DVT .

Sites / Locations

  • Kasr Alaini

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bioptron light therapy and medical care

medical care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Wound assessment
The wound surface area (ulcer size), lenghth and width will measured using Ruler technique

Secondary Outcome Measures

Full Information

First Posted
May 28, 2020
Last Updated
February 28, 2021
Sponsor
Cairo University
Collaborators
Princess Nourah Bint Abdulrahman University
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1. Study Identification

Unique Protocol Identification Number
NCT04446767
Brief Title
Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer
Official Title
Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
September 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Princess Nourah Bint Abdulrahman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing Disorder
Keywords
diabetes, foot ulcer, polarized light, ;wound healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bioptron light therapy and medical care
Arm Type
Experimental
Arm Description
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
Arm Title
medical care
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
polarized light
Other Intervention Name(s)
bioptron light therapy
Intervention Description
bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks
Intervention Type
Other
Intervention Name(s)
Medical Care
Intervention Description
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
Primary Outcome Measure Information:
Title
Histologic evaluation:
Description
Aerobic microflora will be isolated and controlled on the basis of biogram and antibiogram at the beginning and at the end of treatment
Time Frame
two months
Title
Wound assessment
Description
The wound surface area (ulcer size), lenghth and width will measured using Ruler technique
Time Frame
two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Facility Information:
Facility Name
Kasr Alaini
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36315226
Citation
Taha MM, El-Nagar MM, Elrefaey BH, Elkholy RM, Ali OI, Alkhamees N, Felaya EEE. Effect of Polarized Light Therapy (Bioptron) on Wound Healing and Microbiota in Diabetic Foot Ulcer: A Randomized Controlled Trial. Photobiomodul Photomed Laser Surg. 2022 Dec;40(12):792-799. doi: 10.1089/photob.2021.0175. Epub 2022 Oct 28.
Results Reference
derived

Learn more about this trial

Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer

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