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

NCT ID: NCT06670417

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2025-12-30

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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. It provides 18 individual laser beams used for extravascular blood irradiation (transcutaneous) through radial and ulnar vessels at the wrist site.

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

Group Type: EXPERIMENTAL

Buerger Allen exercise

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Regular wound care

Intervention Type: OTHER

Regular wound care and dressing to the wound and ulcer

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: OTHER

Regular wound care

Regular wound care and dressing to the wound and ulcer

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Heba afifi

lecturer Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy

Giza, Dokki, Egypt

Countries

Egypt

Central Contacts

Hebatullah Emad lecturer Assistant

Role: CONTACT

hebaemad2005@hotmail.com

002 1066103900

Hend Abdel Lecturer

Role: CONTACT

Drhendpt@cu.edu.eg

002 1115507195

Facility Contacts

Hend Abdel Lecturer

Role: primary

Drhendpt@cu.edu.eg

002 1115507195

Other Identifiers

P.T.REC/012/004287

Identifier Type: -

Identifier Source: org_study_id