Ultrasound-Guided Nerve Hydrodissection for Diabetic Lower Limb Entrapment Neuropathy

The goal of this clinical trial is to learn if a single session of ultrasound-guided nerve hydrodissection can relieve symptoms of diabetic lower limb entrapment neuropathy, a condition caused by compressed nerves in the leg that leads to numbness, pain, or muscle weakness in people with diabetes. The main questions it aims to answer are whether nerve hydrodissection improves nerve function (measured by the Toronto Clinical Scoring System) one month after treatment, and whether it relieves pain and improves quality of life. Researchers will compare two groups: one will receive the actual nerve hydrodissection (injection of medicine around the compressed nerve), and the other will receive a sham procedure that involves injecting a small amount of fluid under the skin (not around the nerve). Participants will not know which group they are in, and the researchers who measure the results will also not know. Participants will have four in-person visits over about one month, complete questionnaires about their nerve symptoms, pain, and quality of life, undergo nerve ultrasound at the beginning and at follow-up visits (at 1 month after treatment), and receive either the nerve hydrodissection or the sham procedure at the second visit. All participants will continue their regular diabetes and nerve medication during the study.

NCT Number	NCT07625020
Lead Sponsor	Chongqing Medical University
Conditions	Diabetic Peripheral Neuropathy, Entrapment Neuropathy
Enrollment	266 participants
Start Date	2026-05-20
Primary Completion	2027-05-20 (estimated)
Study Completion	2027-05-20 (estimated)
Updated on ClinicalTrials.gov	2026-06-17