Clinical Research Directory

Randomized, Double-blind, Placebo-controlled, Multicenter Phase IIb Clinical Trial of Spray YJ001 for the Treatment of Diabetic Peripheral Neuropathic Pain

The goal of this clinical trial is to learn if YJ001 Spray can treat diabetic patients with Diabetic Peripheral Neuropathic Pain(DPNP). The main questions it aims to answer are: * Is YJ001 spray effective for patients with diabetic peripheral neuropathic pain(DPNP)？ * The optimal effective dose of YJ001 spray for patients with diabetic peripheral neuropathic pain(DPNP). * Is YJ001 spray safe for patients with diabetic peripheral neuropathic pain(DPNP)？ Researchers will divide YJ001 spray into three different doses of YJ001 spray and compare it with a placebo (a substance that looks similar but does not contain medication) to observe whether YJ001 spray can effectively treat diabetic peripheral neuropathic pain and to determine the optimal effective dose. Participants will: * Apply spray topically to both feet twice daily, with six sprays per foot at each administration.Attend scheduled study visits at baseline and weeks 1, 2, 4, 8, and 12, followed by a visit 1 week after Treatment termination. * Record their symptoms and the number of times they use the spray.

YJ001 Spray for Diabetic Peripheral Neuropathic Pain

The goal of this clinical trial is to learn if YJ001 Spray works to treat diabetic patients with Diabetic Peripheral Neuropathic Pain..It will also learn about the safety of drug YJ001 Spray.This trial is divided into two parts. The first part of the trial is designed as a randomized, double-blind, double-dummy, parallel-controlled, multi-center clinical trial with positive reference product and placebo; the second part is designed as a single-arm, open-label, multi-center clinical trial.In the first part, the trial was divided into the test group, the positive control group, and the placebo group. In the first part,The experimental group received YJ001 spray + clobazam besylate capsule placebo, the positive control group received YJ001 spray placebo + clobazam besylate capsule, and the placebo group received YJ001 spray placebo + clobazam besylate capsule placebo. In the second part, all participants were treated with the investigational product, and 30 trial participants underwent PK blood sample collection according to the protocol. Part I of the trial : To evaluate the efficacy and safety of YJ001 spray in treating diabetic peripheral neuropathic pain. Part 2 of the trial: Evaluate the long-term efficacy and the pharmacokinetic characteristics of YJ001 spray in treating dia betic peripheral neuropathic pain at the clinically recommended dosage. Participants will: Apply spray topically to both feet twice daily, with six sprays per foot at each administration. Visit the clinic once every 1 or 2 or 4 weeks for checkups and tests Complete a study diary daily to record pain intensity, sleep interference, study-drug administration, and spray-related respiratory irritation.

Efficacy and Safety of Mirogabalin in Diabetic Peripheral Neuropathic Pain

The goal of this clinical trial is to learn if drug Mirogabalin works to treat diabetic peripheral neuropathic pain in adults. It will also learn about the safety of the drug Mirogabalin. The main questions it aims to answer are: Does drug mirogabalin reduce neuropathic pain intensity? Is the drug mirogabalin safe in patients with diabetes suffering from neuropathic pain? Does drug mirogabalin improve patients' quality of life (QoL) ( physical, mental, and social well-being)? Researchers will compare drug mirogabalin to drug pregabalin (a drug conventionally used to treat diabetic neuropathic pain) to see if drug mirogabalin works to treat, safe and improve quality of life (QoL) in diabetic neuropathic pain. Participants will: Take drug Mirogabalin or pregabalin every day for 8 weeks Visit the clinic at 1, 2, 4, 6, 8 weeks for checkups

Using Lymphovenous Bypass to Alleviate Diabetic Peripheral Neuropathy

Diabetes is a metabolic disease characterized by high blood sugar levels due to a lack of insulin. Long-term metabolic disorders can cause structural and functional changes in many organs, mainly affecting the vascular system, and leading to complications in the eyes, kidneys, and nervous system. Diabetic Peripheral Neuropathy (DPN) is a common complication, affecting about 50% of patients. According to the Chinese Diabetes Association, DPN is diagnosed when diabetic patients exhibit signs of peripheral nerve dysfunction, as determined by physical examination or electrophysiological testing, after excluding other causes. The prevalence of DPN in diabetic patients is generally over 30%, with 20-30% experiencing significant pain and mobility issues, severely affecting quality of life and increasing the risk of amputation. Prevention and control rely on strict blood sugar management and lifestyle adjustments, as no medication or surgical intervention can cure DPN. The lymphatic system plays an immunological role in regulating immune cell migration and inflammatory responses. Supermicrosurgical lymphovenous bypass (LVB) has become a routine treatment for lymphedema, allowing high-pressure lymph fluid to drain into non-occluded deep venous systems, alleviating lymphedema, restoring TH1 and TH2 balance, reducing oxidative stress, and enhancing antioxidant capacity. LVB may delay DPN progression, alleviate pain (DPNP), and promote diabetic foot ulcer healing. In our clinical experience, a patient with Charcot's neuroarthropathy and chronic plantar ulcers underwent LVB alongside wound care. Five years of follow-up showed complete wound healing without further amputation, despite poor HbA1c control. Thus, we aim to further accumulate clinical experience and data, study histological changes, and confirm the benefits of this surgery to help similar patients.