Clinical Research Directory

Hyperbaric Oxygen Therapy Versus High Power Laser for Diabetic Neuropathy

The purpose of this study is to compare the clinical effects of Hyperbaric Oxygen Therapy (HBOT) versus High-Intensity Laser Therapy (HPLT) on sensorimotor functions and nerve conduction in patients suffering from painful diabetic peripheral neuropathy. Participants are divided into three equal groups. The first group receives a traditional physiotherapy program focused on ankle and foot exercises. The second group receives hyperbaric oxygen therapy sessions in addition to the traditional program. The third group receives high-power MLS laser therapy alongside the traditional program. Investigators look at whether either advanced intervention shows superiority in improving nerve functionality and reducing neuropathic pain.

SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.

The goal of this clinical trial is to determine whether quantitative sensory testing (QST) can be used to classify participants into pain sub-groups and predict who will respond best to certain pain treatments in participants with painful peripheral neuropathy. The analgesic effect is evaluated by measuring pain intensity and Patient Global Impression of Change (PGIC). This study is a 3-period cross-over trial. This means researchers will compare 3 different drugs (pregabalin, duloxetine, and placebo) over a period of 19 weeks. Participants will: * Undergo a quantitative sensory testing (QST) exam. * Provide a blood sample. * Complete questionnaires on the computer. * Take the study drug as instructed.

Effect of Trimetazidine on Endothelin-1 and Clinical Outcomes of Patients With Diabetic Peripheral Neuropathy

The goal of this clinical trial is to investigate if trimetazidine can improve clinical outcomes of patients with diabetic peripheral neuropathy. The main questions it aims to answer are: Does trimetazidine improve the symptoms of diabetic peripheral neuropathy? Does trimetazidine affect endothelin-1 levels? Participants in the interventional arm will receive trimetazidine tablets 35 mg twice daily for three months.

Transcutaneous Pulsed Radiofrequency for the Treatment of Diabetic Peripheral Neuropathy Pain

The purpose of this study is to determine if a non-invasive, electrical pulsed radio frequency (PRF) device can relieve pain and improve function in patients suffering from diabetic nerve pain in their feet, known as pedal diabetic peripheral neuropathy. Patients with this condition often experience severe pain, burning sensations, numbness, and tingling. Current medications for diabetic nerve pain often have unwanted side effects or do not provide sufficient relief. In this single-blind, randomized trial, participants are assigned to receive either an active PRF treatment or a placebo (sham) treatment. Both treatments involve placing the device safely behind the knee (targeting the sciatic nerve) for 10 minutes, once a week for 3 weeks. The main question this study aims to answer is whether the active PRF treatment reduces nerve pain and symptoms significantly more than the placebo, measured by standard symptom questionnaires over a 6-month period.

Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study

The "Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot study (CBD-DPN1)" is a double-blinded, placebo-controlled, crossover pilot study evaluating the efficacy of Cannabidiol (CBD) and full-spectrum CBD (fsCBD) tinctures in treating Diabetic Peripheral Neuropathy (DPN)-associated pain. DPN is a common, highly distressing complication of diabetes, characterized by chronic pain and loss of sensory function, for which currently available treatments primarily offer only symptomatic relief. CBD and fsCBD are being investigated for their potential neuroprotective and analgesic effects by regulating inflammation and oxidative stress. The study aims to recruit 12 to 20 adult participants who have mild to moderate DPN. Subjects will receive either an active treatment (CBD isolate or fsCBD in MCT oil, dosed at 50 mg twice daily for a total of 100 mg daily) or a placebo during two sequential 6-week phases. The overall objective of this pilot phase is primarily methodological: to test and refine the clinical protocol, assess patient compliance and acceptability of the CBD formulations, and generate sufficient data to calculate the necessary sample size for a larger, definitive study. Efficacy will be measured using objective and subjective metrics, including DPN severity (DN4 Assessment Tool and DPNCheck™ for nerve conduction velocity) and pain level (PainDetect Questionnaire). Secondary outcomes include evaluating mood (HADS), sleep quality (MOS Sleep Scale), and quality of life (EQ-5D-5L).

NDS and NSS for Screening Diabetic Neuropathy

Diabetic sensorimotor polyneuropathy is a common complication of diabetes mellitus that can lead to pain, sensory loss, foot ulcers, and disability. Early detection is important, but standard diagnostic tests such as nerve conduction studies are not always easily accessible in routine clinical practice. This study aims to evaluate the accuracy and reliability of two simple clinical tools, the Neuropathy Disability Score (NDS) and the Neuropathy Symptom Score (NSS), for screening diabetic peripheral neuropathy. These tools are based on patient-reported symptoms and bedside neurological examination and may provide a practical alternative for early detection. In this cross-sectional diagnostic accuracy study, adult patients with diabetes will be recruited from King Chulalongkorn Memorial Hospital. Participants will undergo clinical assessments, questionnaires, laboratory investigations, and neurophysiological testing, including nerve conduction studies, which will serve as the reference standard. The performance of NDS and NSS will be analyzed to determine their sensitivity, specificity, and overall diagnostic value. The results of this study may support the use of simple, accessible screening tools for early identification of diabetic neuropathy, potentially improving patient care and reducing complications.

Medtronic Inceptiv™ Closed-Loop DTM Spinal Cord Stimulation for Painful Diabetic Peripheral Neuropathy

This study is conducted to evaluate a new way of using spinal cord stimulation (SCS) in people with painful diabetic peripheral neuropathy (DPN). The device used is the Medtronic Inceptiv SCS, which is already approved by the U.S. FDA for treatment of chronic pain. In this study, the system will be programmed to deliver Differential Target Multiplexed (DTM) stimulation with closed-loop feedback using signals from the spinal cord (ECAPs). Up to 25 participants will take part in the study, beginning with a short trial phase and continuing to a permanent implant if the trial is successful. Participants will be followed for 12 months after implant. The main goal is to see whether this therapy can safely and effectively reduce pain in people with diabetic neuropathy. Other measures include physical function, symptom profiles, treatment satisfaction, and monitoring for any side effects.