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The Effect of Combined 650 nm and Infrared Laser on Chronic Diabetic Foot Ulcer Surface Area: (wounds)

Primary Purpose

Diabetic Foot, Wound Heal

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

laser therapy

About this trial

This is an interventional treatment trial for Diabetic Foot focused on measuring 650 nm laser, infrared laser, chronic diabetic foot ulcer, wound surface area

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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:

Patients with vascular disease
Patients with fixed ankle deformity as Charcot foot or stiffness
Patients with any type of osteomyelitis associated with DFU
Patients with renal or hepatic failure
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.

Sites / Locations

National Institute of Laser Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

laser sequential mode

laser seperate mode

traditional wound care

Arm Description

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

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

(II) Traditional wound care inform of Wound care treatment Debridement to remove necrotic tissue Irrigation of the wound by normal saline Change dressing daily to protect wound from infection Foot care Wash feet daily, dry carefully especially between toe Avoid extreme temperatures Inspection daily of foot blisters Foot wear Avoid walking bare foot Properly fitted shoes Avoid wearing open-toed shoes

Outcomes

Primary Outcome Measures

percent of wound size measurement methods

weekly by a ruler (wound area was calculated by measuring and multiplying the greatest length by the greatest width perpendicular to the greatest length) a sterile transparent film sheet

percent of wounds complete closure

measure percent of wounds complete closure in each group

Secondary Outcome Measures

percent of each type of wound cause

different wound cause diabetic foot ulcers and healing time

percent of each wound location

different wound location in diabetic foot ulcers and healing time

percent of days needed for surface area reduction

measure the days needed to decrease surface area in each group

Full Information

NCT ID

NCT05517863

First Posted

August 24, 2022

Last Updated

October 19, 2023

Sponsor

Heidy F. Ahmed

1. Study Identification

Unique Protocol Identification Number

NCT05517863

Brief Title

The Effect of Combined 650 nm and Infrared Laser on Chronic Diabetic Foot Ulcer Surface Area:

Acronym

wounds

Official Title

The Effect of Combined 650 nm and Infrared Laser on Chronic Diabetic Foot Ulcer Surface Area: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

March 1, 2022 (Actual)

Primary Completion Date

July 12, 2022 (Actual)

Study Completion Date

July 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Heidy F. Ahmed

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot, Wound Heal

Keywords

650 nm laser, infrared laser, chronic diabetic foot ulcer, wound surface area

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Masking

ParticipantOutcomes 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

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

laser sequential mode

Arm Type

Experimental

Arm Description

Arm Title

laser seperate mode

Arm Type

Experimental

Arm Description

Arm Title

traditional wound care

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

laser therapy

Intervention Description

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: 980 nm for wound decontamination, improve circulation, lymphatic drainage 915 nm enhances O2 delivery 810 nm increases ATP production 650 nm accelerate surface healing, tissue regeneration plus traditional wound treatment mentioned before

Primary Outcome Measure Information:

Title

percent of wound size measurement methods

Description

weekly by a ruler (wound area was calculated by measuring and multiplying the greatest length by the greatest width perpendicular to the greatest length) a sterile transparent film sheet

Time Frame

two consecutive months

Title

percent of wounds complete closure

Description

measure percent of wounds complete closure in each group

Time Frame

two consecutive months

Secondary Outcome Measure Information:

Title

percent of each type of wound cause

Description

different wound cause diabetic foot ulcers and healing time

Time Frame

two consecutive months

Title

percent of each wound location

Description

different wound location in diabetic foot ulcers and healing time

Time Frame

two consecutive months

Title

percent of days needed for surface area reduction

Description

measure the days needed to decrease surface area in each group

Time Frame

two consecutive months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Patients with vascular disease Patients with fixed ankle deformity as Charcot foot or stiffness Patients with any type of osteomyelitis associated with DFU Patients with renal or hepatic failure 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mahmoud S El Basiouny

Organizational Affiliation

national institute of laser sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Heidy F Ahmed, master

Organizational Affiliation

Kasr al aini

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institute of Laser Sciences

City

Giza

ZIP/Postal Code

12613

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

Citation

Experimental Study of the Effect of Photobiomodulation Therapy on the Regulation of the Healing Process of Chronic Wounds

Results Reference

background

Citation

Hamblin, M. R., Agrawal, T., & de Sousa, M. (Eds.). (2016). Handbook of low-level laser therapy. CRC Press.

Results Reference

background

PubMed Identifier

30534349

Citation

Rupel K, Zupin L, Colliva A, Kamada A, Poropat A, Ottaviani G, Gobbo M, Fanfoni L, Gratton R, Santoro M, Di Lenarda R, Biasotto M, Zacchigna S. Photobiomodulation at Multiple Wavelengths Differentially Modulates Oxidative Stress In Vitro and In Vivo. Oxid Med Cell Longev. 2018 Nov 11;2018:6510159. doi: 10.1155/2018/6510159. eCollection 2018.

Results Reference

background

PubMed Identifier

31523781

Citation

Lima AMCT, da Silva Sergio LP, de Souza da Fonseca A. Photobiomodulation via multiple-wavelength radiations. Lasers Med Sci. 2020 Mar;35(2):307-316. doi: 10.1007/s10103-019-02879-1. Epub 2019 Sep 16.

Results Reference

background

PubMed Identifier

30889017

Citation

Mosca RC, Ong AA, Albasha O, Bass K, Arany P. Photobiomodulation Therapy for Wound Care: A Potent, Noninvasive, Photoceutical Approach. Adv Skin Wound Care. 2019 Apr;32(4):157-167. doi: 10.1097/01.ASW.0000553600.97572.d2.

Results Reference

background

PubMed Identifier

34681882

Citation

Leyane TS, Jere SW, Houreld NN. Cellular Signalling and Photobiomodulation in Chronic Wound Repair. Int J Mol Sci. 2021 Oct 18;22(20):11223. doi: 10.3390/ijms222011223.

Results Reference

background

PubMed Identifier

22923269

Citation

de Sousa AP, Paraguassu GM, Silveira NT, de Souza J, Cangussu MC, dos Santos JN, Pinheiro AL. Laser and LED phototherapies on angiogenesis. Lasers Med Sci. 2013 May;28(3):981-7. doi: 10.1007/s10103-012-1187-z. Epub 2012 Aug 25.

Results Reference

background

PubMed Identifier

29123633

Citation

Moskvin SV, Geynitz AV, Askhadulin EV. Efficiency of a New Combined Laser Therapy in Patients With Trophic Ulcers of Lower Extremities and Chronic Venous Insufficiency. J Lasers Med Sci. 2017 Summer;8(3):132-135. doi: 10.15171/jlms.2017.24. Epub 2017 Jun 27.

Results Reference

background

PubMed Identifier

25653799

Citation

de Lima FJ, Barbosa FT, de Sousa-Rodrigues CF. Use alone or in Combination of Red and Infrared Laser in Skin Wounds. J Lasers Med Sci. 2014 Spring;5(2):51-7.

Results Reference

background

PubMed Identifier

21214389

Citation

Santos NR, de M Sobrinho JB, Almeida PF, Ribeiro AA, Cangussu MC, dos Santos JN, Pinheiro AL. Influence of the combination of infrared and red laser light on the healing of cutaneous wounds infected by Staphylococcus aureus. Photomed Laser Surg. 2011 Mar;29(3):177-82. doi: 10.1089/pho.2009.2749. Epub 2011 Jan 8.

Results Reference

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The Effect of Combined 650 nm and Infrared Laser on Chronic Diabetic Foot Ulcer Surface Area:

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