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

NCT05517863 | Completed DMC

• 1 other identifier: LASER.REC/2022
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Foot; Wound Heal

Keywords

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

Outcome Measures

Primary Outcomes (2)

• percent of wound size measurement methods

  weekly by 1. a ruler (wound area was calculated by measuring and multiplying the greatest length by the greatest width perpendicular to the greatest length) 2. a sterile transparent film sheet

  two consecutive months

• percent of wounds complete closure

  measure percent of wounds complete closure in each group

  two consecutive months

Secondary Outcomes (3)

• percent of each type of wound cause

  two consecutive months

• percent of each wound location

  two consecutive months

• percent of days needed for surface area reduction

  two consecutive months

Study Arms (3)

laser sequential mode

EXPERIMENTAL

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

laser seperate mode

EXPERIMENTAL

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

traditional wound care

ACTIVE COMPARATOR

(II) 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

Interventions

laser therapy DEVICE

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

laser seperate mode; laser sequential mode; traditional wound care

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heidy F. Ahmed: lead

Study Sites (1)

National Institute of Laser Sciences

Giza, 12613, Egypt

Location

Related Publications (10)

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

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 30534349 BACKGROUND

• 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.

  PMID: 31523781 BACKGROUND

• 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.

  PMID: 30889017 BACKGROUND

• 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.

  PMID: 34681882 BACKGROUND

• 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.

  PMID: 22923269 BACKGROUND

• 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.

  PMID: 29123633 BACKGROUND

• 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.

  PMID: 25653799 BACKGROUND

• 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.

  PMID: 21214389 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Mahmoud S El Basiouny

  national institute of laser sciences

  PRINCIPAL INVESTIGATOR

• Heidy F Ahmed, master

  Kasr al aini

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of physical therapy at Al kasr Al Anini teaching hospital, Cairo, Egypt

Model Details: 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

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: March 1, 2022
• Primary Completion: July 12, 2022
• Study Completion: July 27, 2022
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: In the next month of registration.
• Access Criteria: Information will be available upon request through the following e-mail: heidy.fouad@gmail.com.

Locations

EG (1)