Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer

February 28, 2021 updated by: Mona Mohamed Taha, Cairo University
Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Kasr Alaini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bioptron light therapy and medical care
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
bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks
Other Names:
  • bioptron light therapy
Active Comparator: medical care
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histologic evaluation:
Time Frame: two months
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
Time Frame: two months
The wound surface area (ulcer size), lenghth and width will measured using Ruler technique
two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

Princess Nourah Bint Abdulrahman University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2020

Primary Completion (Actual)

August 30, 2020

Study Completion (Actual)

September 5, 2020

Study Registration Dates

First Submitted

May 28, 2020

First Submitted That Met QC Criteria

June 24, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 28, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T REC/017/00482.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wound Healing Disorder

Clinical Trials on polarized light

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe