The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer
NCT ID: NCT05739214
Last Updated: 2023-10-23
Study Results
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Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2022-08-01
2023-01-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
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
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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
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Heidy F. Ahmed
Doctor of physical therapy certified wound specialist at Al kasr Al Anini teaching hospital, Cairo, Egypt
Principal Investigators
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Mahmoud S El Basiouny, professor
Role: PRINCIPAL_INVESTIGATOR
national institute of laser sciences
Heidy F Ahmed, master
Role: PRINCIPAL_INVESTIGATOR
Kasr al aini
Locations
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Al Kasr Al Aini Teaching Hospital
Giza, , Egypt
Countries
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References
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Hegazi R, El-Gamal M, Abdel-Hady N, Hamdy O. Epidemiology of and Risk Factors for Type 2 Diabetes in Egypt. Ann Glob Health. 2015 Nov-Dec;81(6):814-20. doi: 10.1016/j.aogh.2015.12.011.
Banik PC, Barua L, Moniruzzaman M, Mondal R, Zaman F, Ali L. Risk of diabetic foot ulcer and its associated factors among Bangladeshi subjects: a multicentric cross-sectional study. BMJ Open. 2020 Feb 28;10(2):e034058. doi: 10.1136/bmjopen-2019-034058.
American Diabetes Association. Peripheral arterial disease in people with diabetes. Diabetes Care. 2003 Dec;26(12):3333-41. doi: 10.2337/diacare.26.12.3333. No abstract available.
Vinik AI, Erbas T, Park TS, Nolan R, Pittenger GL. Platelet dysfunction in type 2 diabetes. Diabetes Care. 2001 Aug;24(8):1476-85. doi: 10.2337/diacare.24.8.1476.
Sorensen MLB, Jansen RB, Wilbek Fabricius T, Jorgensen B, Svendsen OL. Healing of Diabetic Foot Ulcers in Patients Treated at the Copenhagen Wound Healing Center in 1999/2000 and in 2011/2012. J Diabetes Res. 2019 Sep 8;2019:6429575. doi: 10.1155/2019/6429575. eCollection 2019.
American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2009 Jan;32 Suppl 1(Suppl 1):S62-7. doi: 10.2337/dc09-S062. No abstract available.
Cunha JLS, Carvalho FMA, Pereira Filho RN, Ribeiro MAG, de Albuquerque-Junior RLC. Effects of Different Protocols of Low-Level Laser Therapy on Collagen Deposition in Wound Healing. Braz Dent J. 2019 Jul 22;30(4):317-324. doi: 10.1590/0103-6440201902400.
8) Brandão, M. G. S. A., Ximenes, M. A. M., de Oliveira Ramalho, A., Veras, V. S., Barros, L. M., & de Araújo, T. M. (2020). Effects of low-level laser therapy on the healing of foot ulcers in people with diabetes mellitus. Estima-Brazilian Journal of Enterostomal Therapy, 18, e320.
Oyebode O, Houreld NN, Abrahamse H. Photobiomodulation in diabetic wound healing: A review of red and near-infrared wavelength applications. Cell Biochem Funct. 2021 Jul;39(5):596-612. doi: 10.1002/cbf.3629. Epub 2021 Apr 18.
Coerper S, Wicke C, Pfeffer F, Koveker G, Becker HD. Documentation of 7051 chronic wounds using a new computerized system within a network of wound care centers. Arch Surg. 2004 Mar;139(3):251-8. doi: 10.1001/archsurg.139.3.251.
Pierpont YN, Dinh TP, Salas RE, Johnson EL, Wright TG, Robson MC, Payne WG. Obesity and surgical wound healing: a current review. ISRN Obes. 2014 Feb 20;2014:638936. doi: 10.1155/2014/638936. eCollection 2014.
Kaviani A, Djavid GE, Ataie-Fashtami L, Fateh M, Ghodsi M, Salami M, Zand N, Kashef N, Larijani B. A randomized clinical trial on the effect of low-level laser therapy on chronic diabetic foot wound healing: a preliminary report. Photomed Laser Surg. 2011 Feb;29(2):109-14. doi: 10.1089/pho.2009.2680. Epub 2011 Jan 9.
Goralczyk K, Szymanska J, Szot K, Fisz J, Rosc D. Low-level laser irradiation effect on endothelial cells under conditions of hyperglycemia. Lasers Med Sci. 2016 Jul;31(5):825-31. doi: 10.1007/s10103-016-1880-4. Epub 2016 Feb 9.
Ayuk SM, Houreld NN, Abrahamse H. Collagen production in diabetic wounded fibroblasts in response to low-intensity laser irradiation at 660 nm. Diabetes Technol Ther. 2012 Dec;14(12):1110-7. doi: 10.1089/dia.2012.0125. Epub 2012 Oct 11.
Broughton G 2nd, Janis JE, Attinger CE. The basic science of wound healing. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):12S-34S. doi: 10.1097/01.prs.0000225430.42531.c2.
Li S, Wang C, Wang B, Liu L, Tang L, Liu D, Yang G, Zhang L. Efficacy of low-level light therapy for treatment of diabetic foot ulcer: A systematic review and meta-analysis of randomized controlled trials. Diabetes Res Clin Pract. 2018 Sep;143:215-224. doi: 10.1016/j.diabres.2018.07.014. Epub 2018 Jul 23.
Morikawa M, Derynck R, Miyazono K. TGF-beta and the TGF-beta Family: Context-Dependent Roles in Cell and Tissue Physiology. Cold Spring Harb Perspect Biol. 2016 May 2;8(5):a021873. doi: 10.1101/cshperspect.a021873.
Huang J, Chen J, Xiong S, Huang J, Liu Z. The effect of low-level laser therapy on diabetic foot ulcers: A meta-analysis of randomised controlled trials. Int Wound J. 2021 Dec;18(6):763-776. doi: 10.1111/iwj.13577. Epub 2021 Mar 9.
Other Identifiers
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NILES-EC-CU 23/3/3
Identifier Type: -
Identifier Source: org_study_id
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