Tokyo, Dec. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060096) titled 'Effects of Exercise Using Sound Stimulation and Therapeutic Footwear for the Prevention of Foot Wounds in Patients with Diabetes' on Dec. 16.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Gifu University of Health Sciences

Condition: Condition - Type 2 Diabetes Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to clarify the effectiveness of a hybrid therapy that combines exercise therapy using auditory stimulation with shoe therapy for the prevention of foot ulcers in patients with type 2 diabetes. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - In the control group, physical therapists provide standard exercise instruction, including guidance on exercise intensity and frequency, walking instruction, resistance exercise instruction, education on complication prevention, and self-monitoring guidance. The intervention period lasts for one year. We conduct evaluations at baseline and every three months following the exercise instruction. We use a 10-meter walk test at each participant's self-selected comfortable walking speed to assess walking speed, gait sway, and maximum plantar pressure, and we provide feedback based on the results. In addition, we monitor the incidence of foot abnormalities, such as calluses and fissures, as well as the occurrence of foot ulcers throughout the study period. Interventions/Control_2 - In the shoe-therapy group, we provide the same exercise instruction as in the control group and additionally provide diabetic-specific shoes. We instruct participants to wear these shoes consistently during exercise and daily outings, and to perform walking exercises at their self-selected comfortable walking speed. The intervention period lasts for one year. We conduct evaluations at baseline and every three months following the exercise instruction. We use a 10-meter walk test at each participant's self-selected comfortable walking speed to assess walking speed, gait sway, and maximum plantar pressure, and we provide feedback based on the results. In addition, we monitor the incidence of foot abnormalities, such as calluses and fissures, as well as the occurrence of foot ulcers throughout the study period.

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - The eligibility criterion for participants is an age of 75 years or younger. Key exclusion criteria - Exclusion criteria include participants who require orthopedic treatment; those with a history of central nervous system disorders; those with severe diabetic retinopathy or nephropathy; those with severe heart disease; those experiencing foot pain; and those deemed unsuitable for exercise therapy by a physician. Target Size - 66

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2024 Year 06 Month 01 Day Date of IRB - 2024 Year 10 Month 07 Day Anticipated trial start date - 2025 Year 02 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068697

Disclaimer: Curated by HT Syndication.