Tokyo, May 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061479) titled 'A Comprehensive MRI Evaluation of Structural and Physiological Changes in Lower Leg Tissue Associated with Compression from Compression Stockings' on May 11.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - Fukushima Medical University
Condition:
Condition - Healthy volunteer
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate structural and physiological changes in the skin, subcutaneous tissue, and skeletal muscle of the lower leg before and after wearing compression stockings in healthy volunteer, using quantitative MRI measures.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Putting on compression stockings
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Individuals aged 18 to 35 at the time of consent
2. Individuals without obvious edema, skin conditions, or injuries on the lower legs
3. Individuals capable of wearing compression stockings
4. Individuals who consent to undergoing an MRI examination and for whom safety during the MRI examination can be ensured
Key exclusion criteria - 1. Individuals with metal devices or other foreign objects in their bodies due to past surgeries, or those for whom an MRI scan is difficult due to conditions such as claustrophobia
2. Individuals with deep vein thrombosis in the lower limbs, severe peripheral arterial disease, or conditions for which compression therapy is contraindicated
3. Pregnant women or women who may be pregnant
4. Individuals deemed unsuitable by the principal investigator
5. Individuals who have withdrawn their consent to participate in this study
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 05 Month 11 Day
Anticipated trial start date - 2026 Year 05 Month 11 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070347
Disclaimer: Curated by HT Syndication.