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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Diabetic Foot Ulcer (DFU)

Treatments: Other: Buerger Allen exercise; 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; Other: Regular wound care

Study type: Interventional

Funder types: Other

Identifiers

NCT06670417

P.T.REC/012/004287

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 45 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index of 25-34.9 kg/m2.
• Glycated hemoglobin (HbA1c) >7 %.
• ABP index absolute normal (1-1.3)
• Patient with polyneuropathy.
• Patient suffer from diabetes more than 5 years.
• Patient has chronic unhealed diabetic ulcer from 4 weeks up to 6 weeks.

Exclusion criteria

• Patients with history of hypo- hyperglycemic coma.
• Uncontrolled cardiovascular complications.
• Malignancy, Anemia, Hemorrhagic diseases.
• Cardiac peace maker.
• Deep venous thrombosis.
• Osteomyelitis.
• Patients with Monckeberg sclerosis.
• Photosensitivity to laser.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

Group (A) (Experimental A): will receive extravascular low level laser therapy LLLT (laser watch dev

Experimental group

Treatment:

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

B) (Experimental B): will receive Offloading exercise inform of burger allen exercise combined with

Experimental group

Treatment:

Other: Buerger Allen exercise

(C) Control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usua

Experimental group

Treatment:

Other: Regular wound care