The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer

NCT05739214 | Completed DMC

• 1 other identifier: NILES-EC-CU 23/3/3
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Foot; Wound Heal; Collagen Diseases

Keywords

infrared laser; red laser; chronic diabetic foot ulcer; collagen formation

Outcome Measures

Primary Outcomes (2)

• percent of collagen formation

  by histological pictures

  two consecutive months

• percent of wound size measurement methods

  measure percent of wounds decrease surface area

  two consecutive months

Secondary Outcomes (1)

• percent of wounds complete closure

  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

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Al Kasr Al Aini Teaching Hospital

Giza, 12556, Egypt

Location

Related Publications (18)

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• 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.

  PMID: 31583251 BACKGROUND

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  PMID: 19118289 BACKGROUND

• 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.

  PMID: 31340220 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33870502 BACKGROUND

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• 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.

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• 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.

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MeSH Terms

Conditions

Diabetic Foot; Collagen Diseases

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; Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Mahmoud S El Basiouny, professor

  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: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of physical therapy certified wound specialist 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 conventional wound care treatment

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: August 1, 2022
• Primary Completion: January 6, 2023
• Study Completion: January 28, 2023
• 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)