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

Not Applicable

Not yet recruiting

• Conditions: Diabetic Foot Ulcer (DFU)
• Interventions: Other: Buerger Allen exercise; Other: Regular wound care

• Registration Number: NCT06670417
• Lead Sponsor: Cairo University

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2024-10-31
• Study First Submitted QC: 2024-10-31
• Study First Posted: 2024-11-01
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-05
• Study Start: 2024-11-30
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B) (Experimental B): will receive Offloading exercise inform of burger allen exercise combined with	Buerger Allen exercise	-
(C) Control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usua	Regular wound care	-

Primary Outcome Measures

Name	Time	Method
wound surface area	From enrollment to the end of treatment at 2 weeks
Glycated hemoglobin HbA1c	From enrollment to the end of treatment at 12weeks

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Giza, Dokki, Egypt