Low-level Laser Therapy Versus Offloading Exercises on Foot Ulcer Healing in Patients with Type 2 Diabetes
1 other identifier
interventional
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2024
CompletedFirst Posted
Study publicly available on registry
November 1, 2024
CompletedStudy Start
First participant enrolled
November 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedNovember 5, 2024
December 1, 2023
1.1 years
October 31, 2024
November 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
Group (A) (Experimental A): will receive extravascular low level laser therapy LLLT (laser watch dev
EXPERIMENTALB) (Experimental B): will receive Offloading exercise inform of burger allen exercise combined with
EXPERIMENTAL(C) Control group will receive their prescribed hypoglycaemic medications(oral and insulin) and usua
EXPERIMENTALInterventions
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.
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
Regular wound care and dressing to the wound and ulcer
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Physical Therapy
Giza, Dokki, 11432, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer Assistant
Study Record Dates
First Submitted
October 31, 2024
First Posted
November 1, 2024
Study Start
November 30, 2024
Primary Completion
December 30, 2025
Study Completion
December 30, 2025
Last Updated
November 5, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share