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IRCT20241223064142N1 IRCT 2025-01-03 Mashhad University of Medical Sciences The effect of foot position on tissue oxygenation Studying the effect of foot position on tissue oxygenation in diabetic foot ulcers 2025-01-20 anticipated 60 Complete https://irct.ir/trial/80936 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment will be done with Python version 3 using the permutations and random libraries. These two libraries will be used to generate random sequences using the block generation method (here, blocks of 4 and 2 are used, which will be randomly generated and will randomly generate the sequence). N/A Ulcer of lower limb, not elsewhere classified. Intervention 1: Intervention group:The ulcerated leg in patients in this group will be placed on a pillow at an elevation of 15 degrees above the heart level for 24 hours. Intervention 2: Control group: The ulcerated leg in patients in this group will be placed on the bed surface for 24 hours. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information available.
public Fatemeh Khani
Intersection of Namaz Boulevard and Shahid Kaveh Boulevard, Velayat Hospital, Mashhad City
mashhad Iran (Islamic Republic of) 917789001 +98 51 3804 2000 khaniF4012@mums.ac.ir Mashhad University of Medical Sciences scientific Mahdieh Arian Yeganeh
Intersection of Namaz Boulevard and Shahid Kaveh Boulevard, Velayat Hospital, Mashhad City
mashhad Iran (Islamic Republic of) 917789001 +98 51 3804 2000 Ariyanm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with diabetic foot ulcers with grades 2C, 2D, 3C, and 3D based on the Texas criteria Has an arterial ulcer (neuroischemic) without any therapeutic intervention or care in the inpatient ward No medical contraindication to participate in the study No restrictions on foot positioning Absence of diseases such as epilepsy and cognitive disorders, orthopedic, cardiovascular problems, infection, amputation no limit no limit Both Changing the patient's position to a position that is not in line with the study objectives. If the patient is not in the study position for more than two hours. L97 Non-pressure chronic ulcer of lower limb, not elsewhere classified Treatment - Other Treatment - Other Intervention group:The ulcerated leg in patients in this group will be placed on a pillow at an elevation of 15 degrees above the heart level for 24 hours. Control group: The ulcerated leg in patients in this group will be placed on the bed surface for 24 hours. Transcutaneous oxygen pressure. Timepoint: Transcutaneous oxygen pressure measurement before the start of the intervention and 24 hours after the start of the intervention. Method of measurement: In the present study, transcutaneous oxygen pressure measurement was used via a touch screen monitor and a single-channel probe manufactured by Medicap, Germany. Calf circumference. Timepoint: Calf circumference measurement before the start of the intervention and twice during the 24-hour intervention. Method of measurement: Measuring calf circumference with a standard tape measure. Mashhad University of Medical Sciences Approved 2024-12-28 Faculty of Nursing and Midwifery -Mashhad University of Medical Sciences Mashhad, Azadi Square, Mashhad University of Medical Sciences, Faculty of Medicine, First Floor mashhad Razavi Khorasan Iran (Islamic Republic of)