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

Not Applicable

Completed

• Conditions: Wound Heal; Diabetic Foot
• Interventions: Device: laser therapy

• Registration Number: NCT05517863
• Lead Sponsor: Heidy F. Ahmed

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2022-07-12
• Study Completion: 2022-07-27
• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

1. Patients with vascular disease
2. Patients with fixed ankle deformity as Charcot foot or stiffness
3. Patients with any type of osteomyelitis associated with DFU
4. Patients with renal or hepatic failure
5. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laser seperate mode	laser therapy	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 sequential mode	laser therapy	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
traditional wound care	laser therapy	(II) 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

Primary Outcome Measures

Name	Time	Method
percent of wounds complete closure	two consecutive months	measure percent of wounds complete closure in each group
percent of wound size measurement methods	two consecutive months	weekly by; 1. a ruler (wound area was calculated by measuring and multiplying the greatest length by the greatest width perpendicular to the greatest length); 2. a sterile transparent film sheet

Secondary Outcome Measures

Name	Time	Method
percent of each wound location	two consecutive months	different wound location in diabetic foot ulcers and healing time
percent of days needed for surface area reduction	two consecutive months	measure the days needed to decrease surface area in each group
percent of each type of wound cause	two consecutive months	different wound cause diabetic foot ulcers and healing time

Trial Locations

Locations (1)

National Institute of Laser Sciences; 🇪🇬 Giza, Egypt