Back to resultsThe Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer (wounds)
Primary Purpose
Diabetic Foot, Wound Heal, Collagen Diseases
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot focused on measuring infrared laser, red laser, chronic diabetic foot ulcer, collagen formation
Eligibility Criteria
Inclusion Criteria: aged between 18 and 60 years; both gender; Diabetic patients type II; Ulcer lasting longer than two months; diabetic foot ulcer (DFU) grade 1 (Superficial diabetic ulcer, ulcer limited to the dermis, not extending to the subcutis) or grade 2 (Ulcer of the skin extending through the subcutis with exposed tendon or bone and without osteomyelitis or abscess formation) according to the Wagner classification Exclusion Criteria: Patients with fixed ankle deformity as Charcot foot or stiffness; Patients with any type of osteomyelitis associated with DFU; the presence of active infection requiring hospitalization, gangrene, systemic diseases such as collagen-vascular diseases, renal failure, evidence of ischemia; BMI < 30 kg/m2 as Obesity can cause poor perfusion due to vascular insufficiencies; an altered population of immune mediators may lengthen the inflammatory process & decrease oxygenation of subcutaneous adipose tissue which is liable to be infected
Sites / Locations
- Al Kasr Al Aini Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
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
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 collagen formation
by histological pictures
percent of wound size measurement methods
measure percent of wounds decrease surface area
Secondary Outcome Measures
percent of wounds complete closure
measure percent of wounds complete closure in each group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05739214
Brief Title
The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer
Acronym
wounds
Official Title
The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
January 6, 2023 (Actual)
Study Completion Date
January 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objective: investigate The effect of combined red and infrared lasers on histopathology collagen formation in diabetic foot ulcer 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 conventional wound care treatment
Detailed Description
Objective: investigate The effect of combined red and infrared lasers on histopathology collagen formation in diabetic foot ulcer 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 collage formation before and after receiving the treatment protocol for two consequetive months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Wound Heal, Collagen Diseases
Keywords
infrared laser, red laser, chronic diabetic foot ulcer, collagen formation
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 conventional wound care treatment
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
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
Arm Title
laser seperate mode
Arm Type
Experimental
Arm Description
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
Arm Title
traditional wound care
Arm Type
Active Comparator
Arm Description
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
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 collagen formation
Description
by histological pictures
Time Frame
two consecutive months
Title
percent of wound size measurement methods
Description
measure percent of wounds decrease surface area
Time Frame
two consecutive months
Secondary Outcome Measure Information:
Title
percent of wounds complete closure
Description
measure percent of wounds complete closure in each group
Time Frame
two consecutive months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
aged between 18 and 60 years; both gender; Diabetic patients type II; Ulcer lasting longer than two months; diabetic foot ulcer (DFU) grade 1 (Superficial diabetic ulcer, ulcer limited to the dermis, not extending to the subcutis) or grade 2 (Ulcer of the skin extending through the subcutis with exposed tendon or bone and without osteomyelitis or abscess formation) according to the Wagner classification
Exclusion Criteria:
Patients with fixed ankle deformity as Charcot foot or stiffness; Patients with any type of osteomyelitis associated with DFU; the presence of active infection requiring hospitalization, gangrene, systemic diseases such as collagen-vascular diseases, renal failure, evidence of ischemia; BMI < 30 kg/m2 as Obesity can cause poor perfusion due to vascular insufficiencies; an 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, professor
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
Al Kasr Al Aini Teaching Hospital
City
Giza
ZIP/Postal Code
12556
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:
PubMed Identifier
27108148
Citation
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.
Results Reference
background
PubMed Identifier
32114471
Citation
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.
Results Reference
background
PubMed Identifier
14633825
Citation
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.
Results Reference
background
PubMed Identifier
11473089
Citation
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.
Results Reference
background
PubMed Identifier
31583251
Citation
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.
Results Reference
background
PubMed Identifier
19118289
Citation
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.
Results Reference
background
PubMed Identifier
31340220
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
33870502
Citation
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.
Results Reference
background
PubMed Identifier
15006880
Citation
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.
Results Reference
background
PubMed Identifier
24701367
Citation
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.
Results Reference
background
PubMed Identifier
21214368
Citation
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.
Results Reference
background
PubMed Identifier
26861982
Citation
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.
Results Reference
background
PubMed Identifier
23057714
Citation
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.
Results Reference
background
PubMed Identifier
16799372
Citation
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.
Results Reference
background
PubMed Identifier
30009935
Citation
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.
Results Reference
background
PubMed Identifier
27141051
Citation
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.
Results Reference
background
PubMed Identifier
33751853
Citation
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.
Results Reference
background
Learn more about this trial
The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer
We'll reach out to this number within 24 hrs