Diabetic Peripheral Neuropathy (DPN)

Diabetic peripheral neuropathy (DPN) is a common complication of type 2 diabetes mellitus, affecting 35%-50% of diabetic patients. Its pathogenesis involves metabolic disorders induced by hyperglycemia and dyslipidemia, leading to irreversible damage to neurons and vascular endothelial cells. Distal symmetric polyneuropathy (DSPN) is the most representative form, characterized by distal pain, numbness, and sensory loss, which may progress to ulcers, gangrene, and even amputation in severe cases. Current modern medical treatments for DPN primarily focus on nutritional nerve support, antioxidative stress, and microcirculation improvement, but these approaches are limited in variety and may carry side effects. Traditional Chinese Medicine (TCM) offers advantages including higher safety and diverse therapeutic options. Based on long-term clinical observation, our research group proposes that the core pathogenesis of DPN is Qi-Yin deficiency with blood stasis obstructing collaterals. The treatment principle is to nourish Yin, supplement Qi, activate blood circulation, and unblock collaterals, with Zuogui Jiangtang Shuluo Formula (ZGJTSLF) as the primary prescription. Previous studies have shown that ZGJTSLF can improve TCSS scores and nerve conduction velocity in DPN patients compared with mecobalamin, but high-level evidence is still lacking. This randomized, parallel-controlled trial aims to evaluate the clinical efficacy of ZGJTSLF in treating DPN, with TCSS score and nerve conduction velocity as primary outcomes. Metabolomics and lipidomics will be employed to compare metabolic profiles between healthy controls and DPN patients before and after ZGJTSLF treatment, aiming to identify potential biomarkers and explore the underlying mechanisms.

The purpose of this clinical trial is to compare the efficacy of benfotiamine with vitamin B1-6-12 in reducing sensory neuropathy symptoms, numbness and pain in patients with diabetic peripheral neuropathy. The main questions this study aims to answer are: * Does benfotiamine reduce overall sensory neuropathy symptoms more effectively than vitamin B1-6-12? * Does benfotiamine reduce numbness more effectively than vitamin B1-6-12? * Does benfotiamine reduce pain more effectively than vitamin B1-6-12? Researchers will compare benfotiamine with vitamin B1-6-12 in a double-blind study. Both treatments will be manufactured as visually identical study medications to maintain blinding. The study will evaluate whether benfotiamine provides greater improvement in sensory neuropathy symptoms, numbness, and pain than vitamin B1-6-12 in patients with diabetic peripheral neuropathy. Participants will: * undergo screening for vitamin B12 deficiency before enrollment. Patients with vitamin B12 deficiency will not be eligible for participation. * randomly assigned to receive either benfotiamine or vitamin B1-6-12, taken orally twice daily for 3 months. * attend two on-site clinic visits (baseline and the end of the study) and complete two telephone follow-up assessments during the study. * continue their usual medications throughout the study, provided that no new neuropathic pain medications are initiated and the dose of existing neuropathic pain medications remains unchanged.

Diabetic peripheral neuropathy (DPN) is a common and serious complication of diabetes that causes numbness, pain, and weakness, often starting in the feet. Currently, there is no cure, and early diagnosis is difficult with standard tests alone. This observational study aims to find better ways to detect DPN in its early stages. The researchers will use high-frequency ultrasound, a painless and non-invasive imaging tool, to measure two things in patients with type 2 diabetes: the cross-sectional area of the sciatic nerve (to look for swelling) and the blood flow velocity in the inferior gluteal artery (a vessel that supplies the nerve).In parallel, a bioinformatics analysis has identified a key target gene, Matrix Metalloproteinase 9(MMP9), which may play a role in nerve damage through a specific signaling pathway. The level of this protein will be measured in the patients' blood. A total of 120 participants will be grouped by the severity of their nerve damage, assessed by Toronto Clinical Scoring System (TCSS). The study will investigate whether the ultrasound measurements correlate with the clinical scores, nerve conduction studies, and the blood levels of the target protein. The ultimate goal is to combine these ultrasound structure, blood flow function, and molecular markers to build a more accurate tool for the early diagnosis and precise management of DPN, bridging the gap from early warning to mechanism-based care.

The aim of this study is to determine the comparative effects of plantar intrinsic muscles exercises and three-dimensional ankle foot exercises on balance, gait and fall risk in patients with diabetic peripheral neuropathy.

This clinical trial aims to evaluate the efficacy and safety of human umbilical cord mesenchymal stem cell (hUC-MSC) injection in the treatment of adults with moderate to severe diabetic peripheral neuropathy. Researchers will compare hUC-MSCs injection combined with conventional therapy (experimental group) to conventional therapy alone (control group) to see if hUC-MSCs work to treat diabetic peripheral neuropathy. The experimental group will receive three injections of hUC-MSCs (on Day 0, Day 7, and Day 28) while continuing conventional therapy, whereas the control group will receive conventional therapy only. Participants will undergo regular follow-ups for checkups and tests over a 24-week period. The primary endpoint of the study is the change in the Toronto Clinical Scoring System (TCSS) score at Week 24. Safety assessments will be conducted throughout the entire study period, with extended follow-up until Week 104 to evaluate long-term safety.

Diabetic peripheral neuropathy (DPN) is a common and disabling complication of diabetes. Many patients experience pain, numbness, and impaired quality of life, while currently available treatments may have limited benefit or cause adverse effects. Electroacupuncture (EA) may provide a safe, non-pharmacological treatment option, but further clinical evidence is needed. The purpose of this study is to evaluate the efficacy and potential mechanisms of low-frequency (2 Hz) electroacupuncture in patients with DPN. In this prospective, randomized, sham-controlled trial, participants will be assigned to either a verum 2 Hz EA group or a sham EA group. The study will assess nerve conduction velocity, pain intensity, serum neurotrophic factors and inflammatory cytokines, and quality of life. This study is intended to provide clinical evidence on the use of low-frequency EA for DPN and to examine whether its effects are related to neurotrophic and inflammatory pathways.

This part of the study enrolled 30 sex- and age-matched healthy controls, 30 diabetic patients without peripheral neuropathy, and 30 patients with diabetic peripheral neuropathy (DPN). Blood samples were collected from the participants, and serum was isolated for transcriptomics and untargeted metabolomics analysis using liquid chromatography-mass spectrometry (LC-MS) to characterize the metabolic profile of DPN. Through differential comparison analysis, serum biomarkers associated with DPN were identified and further correlated with clinical parameters. This approach aims to establish early diagnostic markers for DPN and provide scientific evidence for understanding the complex mechanisms underlying DPN, thereby offering new insights into potential therapeutic strategies.

his randomized clinical trial evaluates the comparative effectiveness of Tai Chi and Modified-Otago exercise programs on pain reduction, balance improvement, and motor function in patients diagnosed with diabetic peripheral neuropathy (DPN). DPN is a common complication of Type 2 Diabetes Mellitus that significantly impairs quality of life through chronic pain, balance deficits, and decreased functional mobility. While pharmacological treatments are commonly used, they often result in adverse side effects, creating a growing need for non-pharmacological interventions like therapeutic exercises. Tai Chi, a traditional Chinese exercise combining slow movements and mental focus, has shown benefits in improving mobility and reducing fall risks in chronic disease populations. The Modified-Otago program, originally developed to prevent falls in the elderly, emphasizes strength and balance training through structured exercise routines. A total of 36 participants (aged 40-80 years) with at least a 5-year history of Type 2 diabetes and a minimum pain score of ≥3 on the Numeric Pain Rating Scale (NPRS) will be recruited. Participants will be randomly allocated to either the Tai Chi group or the Modified-Otago group. Both groups will receive 24 sessions over an 8-week period (3 sessions per week), along with baseline interventions such as heating pad application, TENS, and warm-up/cool-down routines. Primary outcome measures include NPRS for pain, the Berg Balance Scale (BBS) for balance, and the Dynamic Gait Index (DGI) for motor function. Assessments will be conducted at baseline, post-intervention, and two weeks post-treatment. Data will be analyzed using SPSS version 26 to determine within-group and between-group differences. This study aims to inform clinicians about effective exercise strategies for improving physical function in patients with DPN and potentially establish evidence-based rehabilitation protocols.