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

Heidy F. Ahmed

Status: Completed

Conditions: Diabetic Foot; Wound Heal

Treatments: Device: laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05517863

LASER.REC/2022

Details and patient eligibility

About

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

Full 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

Enrollment: 45 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

45 participants in 3 patient groups

laser sequential mode

Experimental group

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

Treatment:

Device: laser therapy

laser seperate mode

Experimental group

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

Treatment:

Device: laser therapy

traditional wound care

Active Comparator group

Description:

(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

Treatment:

Device: laser therapy