The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer (wounds)

October 19, 2023 updated by: Heidy F. Ahmed, Cairo University

The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer: a Randomized Controlled Trial

Objective: investigate The effect of combined red and infrared lasers on histopathology collagen formation in diabetic foot ulcer 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 conventional wound care treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: investigate The effect of combined red and infrared lasers on histopathology collagen formation in diabetic foot ulcer 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 collage formation before and after receiving the treatment protocol for two consequetive months

Study Type

Interventional

Enrollment (Actual)

45

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
      • Giza, Egypt, 12556
        • Al Kasr Al Aini Teaching Hospital

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • aged between 18 and 60 years; both gender; Diabetic patients type II; Ulcer lasting longer than two months; diabetic foot ulcer (DFU) grade 1 (Superficial diabetic ulcer, ulcer limited to the dermis, not extending to the subcutis) or grade 2 (Ulcer of the skin extending through the subcutis with exposed tendon or bone and without osteomyelitis or abscess formation) according to the Wagner classification

Exclusion Criteria:

  • Patients with fixed ankle deformity as Charcot foot or stiffness; Patients with any type of osteomyelitis associated with DFU; the presence of active infection requiring hospitalization, gangrene, systemic diseases such as collagen-vascular diseases, renal failure, evidence of ischemia; BMI < 30 kg/m2 as Obesity can cause poor perfusion due to vascular insufficiencies; an altered population of immune mediators may lengthen the inflammatory process & decrease oxygenation of subcutaneous adipose tissue which is liable to be infected

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: laser sequential mode
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

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
Experimental: laser seperate mode
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

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
Active Comparator: traditional wound care

Traditional wound care inform of

  1. Wound care treatment

    • Debridement to remove necrotic tissue
    • Irrigation of the wound by normal saline
    • Change dressing daily to protect wound from infection

  2. Foot care

    • Wash feet daily, dry carefully especially between toe
    • Avoid extreme temperatures
    • Inspection daily of foot blisters

  3. Foot wear

    • Avoid walking bare foot
    • Properly fitted shoes
    • Avoid wearing open-toed shoes
Device: laser 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percent of collagen formation
Time Frame: two consecutive months
by histological pictures
two consecutive months
percent of wound size measurement methods
Time Frame: two consecutive months
measure percent of wounds decrease surface area
two consecutive months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percent of wounds complete closure
Time Frame: two consecutive months
measure percent of wounds complete closure in each group
two consecutive months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Heidy F Ahmed, master, Kasr Al Aini
  • Principal Investigator: Mahmoud S El Basiouny, professor, National Institute of Laser Sciences

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)

August 1, 2022

Primary Completion (Actual)

January 6, 2023

Study Completion (Actual)

January 28, 2023

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 22, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NILES-EC-CU 23/3/3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected individual participant data (IPD), all IPD that underline results in a publication.

IPD Sharing Time Frame

In the next month of registration.

IPD Sharing Access Criteria

Information will be available upon request through the following e-mail: heidy.fouad@gmail.com.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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.

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