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

Last updated: November 4, 2024
Sponsor: Cairo University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Ulcers

Treatment

Hypoglycemics Oral

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

Buerger Allen exercise

Clinical Study ID

NCT06670417
P.T.REC/012/004287
  • Ages 45-55
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 60
Treatment Group(s): 4
Primary Treatment: Hypoglycemics Oral
Phase:
Study Start date:
November 30, 2024
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Faculty of Physical Therapy

    Giza, Dokki 11432
    Egypt

    Site Not Available

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