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OpenTrials
Completed

NCT Number: NCT05739214

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

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

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Collagen Diseases Connective Tissue Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases Wound Heal

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Kasr Al Aini Teaching Hospital

Giza, 12556, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • 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 outcomes

  1. percent of collagen formation

    Time frame: two consecutive months

    by histological pictures

  2. percent of wound size measurement methods

    Time frame: two consecutive months

    measure percent of wounds decrease surface area

Secondary outcomes

  1. percent of wounds complete closure

    Time frame: two consecutive months

    measure percent of wounds complete closure in each group

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Effect of Combined Red and Infrared Lasers on Histopathology Collagen Formation in Diabetic Foot Ulcer: a Randomized Controlled Trial

Acronym: wounds

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 22, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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