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Clinical study of wearable low-intensity ultrasound (LIUS) in the treatment of patients with diabetic peripheral neuropathy (DPN)

Clinical study of wearable low-intensity ultrasound (LIUS) in the treatment of patients with diabetic peripheral neuropathy (DPN)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095150
Enrollment
Unknown
Registered
2025-01-02
Start date
2025-01-02
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic peripheral neuropathy

Interventions

Sponsors

Shanghai Jiao Tong University School of Medicine Affiliated Sixth People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1)ages between 18 and 70 years; 2)in accordance with the diagnostic criteria of the World Health Organization for diabetes in 1999; 3)HbA1c 3; 10)More than one of the four symptoms of TSS must appear continuously in the past 3 months; 11)Compliance with medication and treatment during the introduction period 85-100%.

Exclusion criteria

Exclusion criteria: 1)Patients with symptomatic peripheral vascular disease, active foot ulcers and / or previous amputation; 2)Drug and / or alcohol dependence, mental illness; 3)The skin of the site treated by ultrasound is damaged or broken; 4)Use large doses of painkillers (such as glucocorticoids) or illegal drugs (such as opioids) before screening and ultrasound treatment; 5)bleeding tendency disease; 6)Malignant tumor of any organ system within 5 years; 7) The patient underwent surgery within 4 weeks before signing the informed consent form, or major surgical operations were planned during the study; 8)Important medical issues, including uncontrollable hypertension (BP = 180 / 120mmHg), refractory heart failure, unstable arrhythmias, unstable symptomatic coronary artery ischemia, or any other disease that researchers believe may impair the patient's immune function; 9)Women with low immunity during pregnancy and lactation; 10)People with previous history of mental illness or cognitive impairment; 11)Participate in other clinical researchers at the same time. 12) Patients who are unable to communicate with the investigator or staff.

Design outcomes

Primary

MeasureTime frame
TSS;

Secondary

MeasureTime frame
NIS;Nerve conduction velocity;Vibration threshold;

Countries

China

Contacts

Public ContactHaoyong Yu

Shanghai Jiao Tong University School of Medicine Affiliated Sixth People’s Hospital

yuhaoyong111@sjtu.edu.cn+86 189 3017 3807

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026