Tokyo, March 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061013) titled 'Effect of post-discharge support for continuing self-exercise on prevention of wound deterioration in patients with diabetic foot' on March 22.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Oitaoka Hospital, Keiwakai Medical Corporation
Condition:
Condition - Diabetic foot
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate the effect of post-discharge support for continuing self-exercise on the prevention of wound deterioration in patients with diabetic foot.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Post-discharge support program for continuing self-exercise. At discharge, patients are provided with educational video content on foot care and exercise therapy including foot inspection, footwear management, lower limb strengthening, and stretching. Patients watch the videos using their smartphones and record daily foot condition and self-care practices on a wound management sheet. Healthcare staff review the records during outpatient visits and provide feedback when necessary.
Interventions/Control_2 - Standard discharge education. Patients receive usual verbal and written instructions regarding foot care and daily management at discharge.
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male and Female
Key inclusion criteria - Patients hospitalized for treatment of diabetic foot who receive rehabilitation therapy
Key exclusion criteria - Patients who have undergone lower limb or foot amputation
Patients with severe cognitive or mental impairment who cannot understand the study
Patients whose wound condition or general condition is unstable and cannot continue rehabilitation
Patients requiring assistance in activities of daily living due to visual impairment
Patients judged to be inappropriate by the principal investigator
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 11 Day
Anticipated trial start date - 2025 Year 11 Month 11 Day
Last follow-up date - 2027 Year 11 Month 11 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069819
Disclaimer: Curated by HT Syndication.