Ultrasound-Guided Nerve Hydrodissection for Diabetic Lower Limb Entrapment Neuropathy: A Randomized, Single-Blind, Sham-Controlled Trial

NCT07625020 | Recruiting DMC

• 1 other identifier: 2026-0264-02
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief 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

Entrapment Neuropathy; Diabetic Peripheral Neuropathy

Keywords

Diabetic peripheral neuropathy; Entrapment Neuropathy; Nerve Hydrodissection

Outcome Measures

Primary Outcomes (1)

• Remission rate of TCSS score

  The remission rate of the Toronto Clinical Scoring System (TCSS) after treatment, defined as a decrease of 1 point or more from baseline, compared between the ultrasound-guided nerve hydrodissection group and the sham treatment group.

  At 1 month after the treatment

Secondary Outcomes (6)

• Change in TCSS from baseline

  Within 5 days and 1 month after the treatment

• Changes in each component of TCSS compared to baseline

  Within 5 days and 1 month after the treatment

• Change in VAS pain score from baseline

  Within 5 days and 1 month after the treatment

• Change in EQ-5D quality of life score from baseline

  Within 5 days and 1 month after the treatment

• Change in ultrasound-measured nerve cross-sectional area (CSA) from baseline

  At 1 month after the treatment

Study Arms (2)

Ultrasound-guided nerve hydrodissection treatment group

EXPERIMENTAL

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: Ultrasound-guided nerve hydrodissection treatment

Sham treatment group

SHAM COMPARATOR

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.

Procedure: Sham treatment

Interventions

Ultrasound-guided nerve hydrodissection treatment PROCEDURE

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.

Also known as: Nerve Hydrodissection

Ultrasound-guided nerve hydrodissection treatment group

Sham treatment PROCEDURE

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.

Sham treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85 years, male or female;
• Diagnosis of DLLEN meeting the following criteria: ① Clinical diagnosis of DPN (presence of DPN clinical symptoms plus at least one positive physical sign, or absence of symptoms but presence of two or more positive physical signs), with other etiologies excluded; ② Presence of unilateral or bilateral lower limb symptoms suggestive of peripheral nerve entrapment, including hypoesthesia/paresthesia in a specific nerve distribution area, pain and/or motor dysfunction, or a positive Tinel sign at the corresponding site; ③ Physical examination findings such as decreased or absent skin sensation in the corresponding nerve distribution area, reduced or absent strength of ankle dorsiflexion or eversion, metatarsophalangeal joint movement disorder, foot drop, or foot inversion; ④ Electrophysiological study showing slowing or blockade of nerve conduction velocity at a specific site (across a narrowed segment); ⑤ Imaging study (nerve ultrasound) showing compression of the corresponding nerve (cross-sectional area at the entrapment site exceeding the upper limit of the reference range, decreased nerve echogenicity, or swelling of the nerve fascicles). Diagnosis requires fulfillment of ①, ②, and ③, plus either ④ or ⑤;
• Inadequate response to adequate treatment with medications such as mecobalamin and α-lipoic acid;
• Understanding of the entire study process and voluntary provision of written informed consent.

You may not qualify if:

• Presence of another clearly identified etiology assessed by the investigator as the primary cause of the patient's current lower limb neurological symptoms, including but not limited to: cervical or lumbar spine disease (e.g., radicular symptoms or sciatica), lower extremity vascular disease, cerebral infarction, thyroid dysfunction, vitamin B12 deficiency, heavy alcohol use history, recent chemotherapy or radiotherapy, drug toxicity, or other non-diabetic causes of neuropathy (e.g., CIDP, cauda equina syndrome, subacute combined degeneration of the spinal cord, Guillain-Barré syndrome);
• Concurrent malignancy, active systemic infection, or immune system disease;
• Lower limb edema due to any cause;
• Skin breakdown or infection at the treatment site below the knee;
• Severe cardiac, hepatic, or renal insufficiency (eGFR \<30 mL/min/1.73m², liver transaminases \>2.5 times the upper limit of normal, or New York Heart Association functional class ≥II);
• Cognitive impairment or severe mental illness;
• Pregnancy or breastfeeding;
• Participation in another interventional clinical trial within the past 3 months;
• Poor compliance, assessed as unlikely to complete the study per protocol;
• Any other condition assessed by the investigator as making the patient unsuitable to complete the trial.

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

MeSH Terms

Conditions

Charcot-Marie-Tooth Disease

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Central Study Contacts

Qingfeng Cheng, PhD

CONTACT

13628482293; cqf19760516@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): May 20, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

CN (1)