The Effect of Combined 650 nm and Infrared Laser on Chronic Diabetic Foot Ulcer Surface Area:
NCT ID: NCT05517863
Last Updated: 2023-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
45 participants
INTERVENTIONAL
2022-03-01
2022-07-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer
NCT05739214
Low Level Laser Therapy and Expression of VEGF, NO, VEGFR-2, HIF-1α in Diabetic Foot Ulcers
NCT02452086
Helium-Neon Laser Therapy Versus Infrared Laser Therapy in Treating Patients With Diabetic Foot Ulcer
NCT03338517
Use of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers
NCT04246814
Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer
NCT03788642
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
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
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
traditional wound care
(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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Patients with fixed ankle deformity as Charcot foot or stiffness
3. Patients with any type of osteomyelitis associated with DFU
4. Patients with renal or hepatic failure
5. 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.
20 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Heidy F. Ahmed
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Heidy F. Ahmed
Doctor of physical therapy at Al kasr Al Anini teaching hospital, Cairo, Egypt
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mahmoud S El Basiouny
Role: PRINCIPAL_INVESTIGATOR
national institute of laser sciences
Heidy F Ahmed, master
Role: PRINCIPAL_INVESTIGATOR
Kasr al aini
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institute of Laser Sciences
Giza, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Experimental Study of the Effect of Photobiomodulation Therapy on the Regulation of the Healing Process of Chronic Wounds
Hamblin, M. R., Agrawal, T., & de Sousa, M. (Eds.). (2016). Handbook of low-level laser therapy. CRC Press.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LASER.REC/2022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.