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Completed

NCT Number: NCT05517863

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

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

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Key information

Conditions

Diabetic Foot Cardiovascular 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

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Laser Sciences

Giza, 12613, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

  • Patients with vascular disease
  • Patients with fixed ankle deformity as Charcot foot or stiffness
  • Patients with any type of osteomyelitis associated with DFU
  • Patients with renal or hepatic failure
  • 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.

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 wound size measurement methods

    Time frame: two consecutive months

    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

  2. percent of wounds complete closure

    Time frame: two consecutive months

    measure percent of wounds complete closure in each group

Secondary outcomes

  1. percent of each type of wound cause

    Time frame: two consecutive months

    different wound cause diabetic foot ulcers and healing time

  2. percent of each wound location

    Time frame: two consecutive months

    different wound location in diabetic foot ulcers and healing time

  3. percent of days needed for surface area reduction

    Time frame: two consecutive months

    measure the days needed to decrease surface area in each group

Sponsors and collaborators

Lead sponsor

Heidy F. Ahmed

Other

Registry information

Official study title

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

Acronym: wounds

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2022
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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