Diabetic Peripheral NeuropathyHUNDNCT07625020
Ultrasound-Guided Nerve Hydrodissection for Diabetic Lower Limb Entrapment Neuropathy
A study testing Ultrasound-guided nerve hydrodissection treatment in people with Diabetic Peripheral Neuropathy and Entrapment Neuropathy, run by Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Entrapment Neuropathy
- What is being tested?
- Ultrasound-guided nerve hydrodissection treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2026to 20 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Qingfeng Cheng, PhD, 13628482293, cqf19760516@163.com
About this study
Official title: Ultrasound-Guided Nerve Hydrodissection for Diabetic Lower Limb Entrapment Neuropathy: A Randomized, Single-Blind, Sham-Controlled Trial
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.
- Being tested
- Ultrasound-guided nerve hydrodissection treatment, Sham treatment
- Keywords
- Diabetic peripheral neuropathy, Entrapment Neuropathy, Nerve Hydrodissection
- Medical subject headings
- Charcot-Marie-Tooth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided nerve hydrodissection treatmentProcedure or surgery
Also called Nerve Hydrodissection
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.
Sham treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate of TCSS score
The Toronto Clinical Scoring System (TCSS) assesses neuropathy symptoms, sensory deficits, and reflexes, with a total score ranging from 0 to 19. Higher scores indicate worse outcomes (more severe neuropathy).
Remission is defined as a decrease of 1 point or more from baseline.
This outcome is compared between the ultrasound-guided nerve hydrodissection group and the sham treatment group.
Measured: At 1 month after the treatment
Secondary outcomes (6)
Change in TCSS from baseline
Changes in TCSS from baseline
Measured: Within 5 days and 1 month after the treatment
Changes in each component of TCSS compared to baseline
Changes in each component of the Toronto Clinical Scoring System (TCSS) from baseline.
The TCSS assesses three components: symptoms, sensory deficits, and reflexes.
Total score range: 0 to 19
Each component has its own sub-score range (symptoms: 0-6, sensory: 0-5, reflexes: 0-8)
Higher scores indicate worse outcomes (more severe neuropathy)
This outcome measures the within-group change from baseline at each follow-up time point.
Measured: Within 5 days and 1 month after the treatment
Change in VAS pain score from baseline
Visual Analogue scale（VAS）Score range: 0-10
Higher scores indicate worse outcomes (more severe pain)
This outcome measures the within-group change from baseline at each follow-up time point.
Measured: Within 5 days and 1 month after the treatment
Change in EQ-5D quality of life score from baseline
Changes in the EuroQol Five-Dimensional Five-Level Questionnaire (EQ-5D-5L) from baseline. The EQ-5D-5L consists of two components:
- Utility index score: Derived from the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) Score range typically from ≤ 0 (worst health state) to 1 (full health) Higher scores indicate better outcomes
- EQ-VAS (Visual Analogue Scale):
Self-rated overall health on a vertical scale
Score range: 0 (worst imaginable health) to 100 (best imaginable health)
Higher scores indicate better outcomes
This outcome measures the within-group change from baseline at each follow-up time point.
Measured: Within 5 days and 1 month after the treatment
Change in ultrasound-measured nerve cross-sectional area (CSA) from baseline
Changes in nerve cross-sectional area measured by ultrasound compared to baseline
Measured: At 1 month after the treatment
Patient Global Impression of Change (PGIC)
Patients' self-assessment of overall change in their condition since the start of treatment, measured by the Patient Global Impression of Change (PGIC) scale.
The PGIC is a 7-point rating scale:
Score range: 1 to 7
Scoring:
- = Very much better
- = Much better
- = A little better
- = No change
- = A little worse
- = Much worse
- = Very much worse Lower scores indicate better outcomes (greater improvement)
Measured: Within 5 days and 1 month after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start20 May 2026 (estimated)
- Primary completion20 May 2027 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng Qing-feng, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625020
- Sponsor's protocol ID
- 2026-0264-02
- Acronym
- HUND
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Nerve Hydrodissection for Diabetic Lower Limb Entrapment Neuropathy: A Randomized, Single-Blind, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07625020
- Acronym / sponsor ID
- HUND / 2026-0264-02
- Keywords
- Diabetic peripheral neuropathy, Entrapment Neuropathy, Nerve Hydrodissection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (estimated)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 20 May 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided nerve hydrodissection treatment group | Experimental | Procedure: Ultrasound-guided nerve hydrodissection treatmentThe 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. |
| Sham treatment group | Sham comparator | Procedure: Sham treatmentThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided nerve hydrodissection treatmentAlso: Nerve HydrodissectionThe 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 or surgery | Ultrasound-guided nerve hydrodissection treatment group |
| Sham treatmentThe 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 or surgery | Sham treatment group |
Primary outcome
Remission rate of TCSS score
Time frame: At 1 month after the treatment
The Toronto Clinical Scoring System (TCSS) assesses neuropathy symptoms, sensory deficits, and reflexes, with a total score ranging from 0 to 19. Higher scores indicate worse outcomes (more severe neuropathy). Remission is defined as a decrease of 1 point or more from baseline. This outcome is compared between the ultrasound-guided nerve hydrodissection group and the sham treatment group.
6 secondary outcomes
Change in TCSS from baseline
Time frame: Within 5 days and 1 month after the treatment
Changes in each component of TCSS compared to baseline
Time frame: Within 5 days and 1 month after the treatment
Change in VAS pain score from baseline
Time frame: Within 5 days and 1 month after the treatment
Change in EQ-5D quality of life score from baseline
Time frame: Within 5 days and 1 month after the treatment
Change in ultrasound-measured nerve cross-sectional area (CSA) from baseline
Time frame: At 1 month after the treatment
Patient Global Impression of Change (PGIC)
Time frame: Within 5 days and 1 month after the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided nerve hydrodissection treatment in people with Diabetic Peripheral Neuropathy and Entrapment Neuropathy, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingfeng Cheng, PhD (13628482293, cqf19760516@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate of TCSS score (time frame: At 1 month after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.