Tokyo, Nov. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059849) titled 'Effects of warm-water foot baths or carbonated-water foot baths on diabetic peripheral neuropathy; A randomized, non-blinded, comparative study' on Nov. 21.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - National Institute for Health Security
Condition:
Condition - Diabetic peripheral neuropathy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of warm-water footbaths and carbonated-water footbaths on peripheral neuropathy and peripheral blood flow in patients with diabetic peripheral neuropathy.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Carbonated footbath group
Participants will receive a footbath using carbonated water generated by a carbonated water generator (Carbo Ceramini, Mitsubishi Chemical Aqua Solutions) for 10 minutes per day over 5 days.
Interventions/Control_2 - Warm-water footbath group
Participants will receive a footbath with warm tap water for 10 minutes per day over 5 days.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Patients aged 20 years or older and under 80 years
2) Patients with type 2 diabetes who have been diagnosed with diabetic peripheral neuropathy
3) Patients currently hospitalized
Key exclusion criteria - 1) Patients with diabetic foot gangrene
2) Patients after lower-limb amputation
3) Patients judged as unsuitable by the attending physician
Target Size - 45
Recruitment Status:
Recruitment status - Terminated
Date of protocol fixation - 2020 Year 02 Month 13 Day
Date of IRB - 2020 Year 04 Month 10 Day
Anticipated trial start date - 2025 Year 11 Month 21 Day
Last follow-up date - 2026 Year 02 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068439
Disclaimer: Curated by HT Syndication.
