NCT06670417

Low-level Laser Therapy Versus Offloading Exercises on Foot Ulcer Healing in Patients with Type 2 Diabetes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 45 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the effect of extravascular Low-level laser therapy (LLLT) versus offloading exercises on foot ulcers healing (DFUs) in type 2 diabetic patients. could include sixty patients with type 2 diabetes associated with diabetic foot ulcer as a complication, their ages ranging from 45 - 55 years. Patients will be selected from Faculty of Medicine (Kasr Al-Aini) Cairo University. They will be referred by the physician after a complete medical evaluation. . The main question it aims to answer is there any significant difference between extravascular low-level laser therapy and offloading exercise on diabetic foot ulcer healing in type 2 diabetic patients ? After clinical assessment patients will be randomly allocated into three groups equal in number: Group (A) (Experimental A): will receive extravascular low level laser therapy LLLT (laser watch device) combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week). Group (B) (Experimental B): will receive Offloading exercise inform of burger allen exercise combined with their prescribed hypoglycaemic medications(oral and insulin) and usual wound care for 12 weeks (3 sessions/ week). Group (C) Control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usual wound care only for 12 weeks (3 sessions/ week).

Conditions

• Diabetic Foot Ulcer (DFU)

Interventions

Type	Name	Description
DEVICE	Low level laser therapy watch: The laser watch device was a semiconductor LLL therapeutic apparatus, (model:SL-03 GaALAs semiconductor) Domer Laser Therapy Watch class 3B 650nm low-level laser light	Low level laser therapy watch: The laser watch device was a semiconductor LLL therapeutic apparatus, (model:SL-03 GaALAs semiconductor) Domer Laser Therapy Watch class 3B 650nm low-level laser light. It provides 18 individual laser beams used for extravascular blood irradiation (transcutaneous) through radial and ulnar vessels at the wrist site.
OTHER	Buerger Allen exercise	Procedure-Keep the Buerger Allen exercise board on the cot. Elevate the lower extremities to an angle of 45 to 90 degree with the help of exercise board. Provided support to the lower extremities to maintain the position. Make the subject to maintain the same position in the same manner until the skin blanches (appears dead white). Lower the feet and the legs below the level of the rest of the body until redness appears (care should be taken that there is no pressure against the back of the knees). Place the legs flat on the bed for a few minutes. Ask the subjects to sit in a relaxed position while each foot is flexed and extended then inverted and everted for 3 minutes till the feet turns entirely pink. Ask the subject to rotate the feet in all the direction. Make the subject to lie quietly for 5 minutes, keeping legs warm with a blanket
OTHER	Regular wound care	Regular wound care and dressing to the wound and ulcer

Timeline

• Start date: 2024-11-30
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2024-11-01
• Last updated: 2024-11-05

Locations

1 site across 1 country: Egypt