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The Therapeutic Effect of Low-intensity Focused Ultrasound on Painful Diabetic Peripheral Neuropathy

NCT05624762 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-11-22

No results posted yet for this study

Summary

Diabetic painful peripheral neuropathy (DPN) constitutes a serious threat to the outcomes of patients with diabetes. Yet, the treatments for targeting the underlying nerve damage and relieving pain are limited. The low-intensity focused ultrasound (LIFU) has been demonstrated to regulate neuronal activity without any concomitant tissue damage. Studies in animal models have shown that LIFU could protect nerve cells against inflammation and oxidative stress, as well as stimulate neurotrophic factor production. In humans, LIFU has been reported to be effective in relieving peripheral neurogenic pain caused by carpal tunnel syndrome and chemotherapy drugs. Thus, we aim to design a randomized controlled double-blind study by using LIFU. The primary endpoint is the patient's pain score (NRS), and the secondary endpoints include Neuropathy Symptom Score (NSS) and Neuropathy Deficit Score (NDS). Through this study, we anticipate establishing a new method for managing painful DPN.

Conditions

  • Painful Diabetic Neuropathy

Interventions

DEVICE

Low-Intensity Focused Ultrasound (LIFU)

LIFU device (LCA200; Chongqing Haifu Medical Technology Co., Ltd., Chongqing, China).

DEVICE

Sham Low-Intensity Focused Ultrasound

Sham Low-Intensity Focused Ultrasound

Sponsors & Collaborators

  • Chongqing Medical University

    lead OTHER

Principal Investigators

  • Qian Ge, Professor · Department of Endocrinology, the First Affiliated Hospital of Chongqing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-07
Primary Completion
2023-12-31
Completion
2024-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05624762 on ClinicalTrials.gov