Ultrasound-Guided Nerve Hydrodissection for Diabetic Lower Limb Entrapment Neuropathy

Summary

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.

Conditions

• Diabetic Peripheral Neuropathy
• Entrapment Neuropathy

Interventions

PROCEDURE

Ultrasound-guided nerve hydrodissection treatment

The patient is placed in a standard position, followed by routine disinfection and draping. A high-frequency ultrasound probe is used and covered with a sterile sheath to clearly visualize the target nerve. Using an in-plane puncture technique, the needle tip is advanced to the perineural fascial plane under real-time guidance. After confirming placement and negative aspiration, a pre-prepared solution of mecobalamin and normal saline is slowly injected. The main sites are the common peroneal nerve (fibular head) and tibial nerve (medial malleolus). Based on preliminary data, a volume of 20 mL is injected, which separates the nerve from surrounding tissues without causing significant discomfort. The fixed volume ensures a standardized procedure. During injection, fluid spread is monitored to ensure it surrounds the nerve and achieves hydrodissection. After injection, the needle is withdrawn, local compression is applied, and the site is covered with a sterile dressing.

PROCEDURE

Sham treatment

The patient is placed in the same standard position, followed by identical disinfection and ultrasound positioning. Under ultrasound guidance, a needle identical in appearance is inserted into the superficial subcutaneous fascia above the target nerve, clearly avoiding the nerve structure. A syringe containing mecobalamin and normal saline is then connected, and a full set of simulated injection maneuvers including aspiration and slow "injection" is performed, while ensuring that the actual volume of fluid delivered is small (less than 5 mL). To simulate a real sensory experience, the operator provides standardized verbal cues during the procedure. After needle withdrawal, local compression and dressing application are performed identically to the treatment group.

Sponsors & Collaborators

• Chongqing Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-20

Primary Completion

2027-05-20

Completion

2027-05-20

Countries

• China

Study Locations