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New treatment option for Diabetic Peripheral Neuropathy
Official title Ultrasound-Guided Nerve Hydrodissection for Diabetic Lower Limb Entrapment Neuropathy
ClinicalTrials.gov ID: NCT07625020
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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...
- 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 likely can't join if
- Presence of another clearly identified etiology assessed by the investigator as the primary cause of the patient's current lower limb neurological...
- 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 \ 2.5 times the upper limit of normal, or New York Heart Association functional class ≥II);
- Cognitive impairment or severe mental illness;
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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 \ 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.