Clinical Research Directory

Effect of TENS on Sensory Parameters in Diabetic Polyneuropathy

Diabetic polyneuropathy is a common complication of diabetes that damages the nerves of the feet and legs. Besides causing pain, it gradually reduces the ability to feel light touch on the sole of the foot. This loss of protective sensation is important because it removes the warning signal that normally prevents unnoticed injuries, which can lead to foot ulcers. Transcutaneous electrical nerve stimulation (TENS) is a non-drug treatment that delivers mild electrical currents through the skin using surface electrodes. It is inexpensive, widely available, and generally well tolerated. Most previous studies of TENS in diabetic polyneuropathy have looked at whether it relieves pain. Far less is known about whether it affects touch sensation, and whether the frequency of the stimulation matters. This study compares three groups of patients with long-standing diabetic polyneuropathy. One group receives high-frequency TENS (100 Hz), one receives low-frequency TENS (5 Hz), and one receives sham stimulation at an intensity too low to have a treatment effect. Treatment is given five days a week for eight weeks, with electrodes placed on the calf and the sole of the foot. The main measure is the lightest touch a participant can feel on the big toe, tested with Semmes-Weinstein monofilaments before and after the eight-week period. Additional measures include electrical and pressure pain thresholds and questionnaires on pain, mood, and quality of life. Participants and the researchers performing the assessments do not know which group each participant is in.

PDN Post Market, Multicenter, Prospective, Global Clinical Study

The purpose of this post-market study is to evaluate the real-world experience of Nevro's Spinal Cord Stimulation (SCS) therapy in patients with chronic, intractable leg pain due to painful diabetic neuropathy (PDN). This is a multicenter, prospective, observational global study, that will partner diabetes management teams with pain physicians to provide an interdisciplinary treatment regimen for PDN patients. Outcomes will be assessed via standardized assessments.

Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities

The goal of this clinical trial is to test perineural injections (injections around a nerve) of incobotulinumtoxin-A in participants with diabetic nerve pain of the feet and lower legs. The main questions it aims to answer are: * Is the treatment safe and effective? * Does the treatment affect participants quality of life, depression, physical activity, daily life, and sensation? Participants will be treated every 12 weeks, for a total of 24 weeks, with either incobotulinumtoxin-A or a placebo.