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

Diabetic Foot Clinical Trial

— wounds  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05517863
• Other study ID #: LASER.REC/2022
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: July 27, 2022

Study information

• Verified date: October 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 27, 2022
• Est. primary completion date: July 12, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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:

1. Patients with vascular disease

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Wound Heal

Intervention

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: 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

Locations

Country	Name	City	State
Egypt	National Institute of Laser Sciences	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Heidy F. Ahmed

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

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. — View 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. — View Citation

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.

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	two consecutive months
Primary	percent of wounds complete closure	measure percent of wounds complete closure in each group	two consecutive months
Secondary	percent of each type of wound cause	different wound cause diabetic foot ulcers and healing time	two consecutive months
Secondary	percent of each wound location	different wound location in diabetic foot ulcers and healing time	two consecutive months
Secondary	percent of days needed for surface area reduction	measure the days needed to decrease surface area in each group	two consecutive months