Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063115) titled 'A Prospective Observational Study of Diabetic Neuropathy in Patients with Diabetes at Our Hospital' on Oct. 1.

Study Type: Observational

Primary Sponsor: Institute - Tohoku Medical and Pharmaceutical University

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

Objective: Narrative objectives1 - This study aims to determine the prevalence of diabetic neuropathy among patients with diabetes who are regularly followed in our department, based on screening examinations for diabetic neuropathy performed as part of routine clinical practice. We will also classify the severity of diabetic neuropathy and clarify the distribution of patients across different severity categories. Furthermore, plantar sensory function, which is particularly susceptible to impairment in diabetes, will be evaluated according to neuropathy severity using the current perception threshold as an objective measure.

In routine diabetes care, diabetic polyneuropathy is often diagnosed using simplified diagnostic criteria because of practical limitations such as restricted consultation time. These criteria consist of the presence of subjective symptoms such as numbness or pain, absence or reduction of the Achilles tendon reflex, and impaired vibratory sensation at the medial malleolus. However, reduced cutaneous sensation is not directly incorporated into these simplified diagnostic criteria.

Loss of protective sensation is an important clinical concern because sensory impairment has been reported to be associated with an increased risk of diabetic foot lesions, foot ulceration, and lower-extremity amputation. Therefore, clarifying the prevalence and severity of sensory impairment in patients with diabetes, particularly in relation to the severity of diabetic neuropathy, may provide clinically meaningful information for the prevention and early detection of diabetic foot complications. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who meet all of the following criteria will be eligible for inclusion: 1. Age 18 years or older at the time of obtaining informed consent. 2. Either sex. 3. Participants who have received an explanation regarding participation in the study and have provided written informed consent. 4. Participants who meet the diagnostic criteria for diabetes mellitus.

Diabetes mellitus is defined as meeting at least one of the following criteria: 1. HbA1c of 6.5% or higher. 2. Fasting plasma glucose of 126 mg/dL or higher, or random plasma glucose of 200 mg/dL or higher. 3. Currently receiving pharmacological treatment for diabetes mellitus.

Participants must meet at least one of criteria 1 through 3 above. Key exclusion criteria - Patients who meet any of the following criteria will be excluded from the study: 1. Patients with an implanted cardiac pacemaker. 2. Patients with an identifiable cause of polyneuropathy other than diabetes mellitus, including vitamin B12 deficiency, chronic inflammatory demyelinating polyneuropathy (CIDP), a history of heavy alcohol consumption, a history of chemotherapy, or uremic neuropathy due to renal failure. 3. Patients receiving dialysis, to exclude the possibility of uremic neuropathy. 4. Patients with a history of lower limb amputation or severe orthopedic disease that prevents appropriate positioning for the examinations. 5. Patients who are unable to understand examination instructions because of cognitive impairment. 6. Patients with trauma, ulceration, or infection of the plantar surface of the foot. Patients may be included after these conditions have healed. 7. Patients considered unsuitable for participation in the study by the principal investigator. Target Size - 200

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 05 Month 27 Day Date of IRB - 2026 Year 07 Month 01 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2028 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072251

Disclaimer: Curated by HT Syndication.