Study of Spinal Cord Stimulation to Improve Pain and Blood Flow in Lower Legs of Adults with Type 2 Diabetes

What this Trial Is About

Researchers are evaluating the impact of spinal cord stimulators on vascular changes in patients with type 2 diabetes mellitus who suffer from painful diabetic neuropathy. This pilot observational study aims to assess improvements in disability, quality of life, micro-circulatory and macro-circulatory changes, and arterial stiffness in the lower extremities caused by diabetes. The study focuses on patients eligible for spinal cord stimulator placement based on their medical condition. Participants will undergo a series of baseline evaluations including questionnaires, clinical and psychological assessments, and detailed vascular testing before receiving a spinal cord stimulator. The stimulator procedure involves placing two temporary trial leads for two weeks, followed by repeated vascular testing and clinical evaluations just before lead removal. The study allows minor adjustments to the stimulator settings within set parameters during the trial. After lead removal, participants have a follow-up visit one week later and may choose further implantation based on their trial experience. Throughout the study, participants will complete various validated questionnaires to assess pain, neuropathy severity, functional capacity, quality of life, medication use, and satisfaction at multiple time points. Vascular assessments include ankle and toe brachial indices, Doppler flowmetry, arterial dilation tests, pulse pressure, and compliance measures. The study consists of five clinic visits over approximately six weeks, including baseline, vascular testing, post-procedure visits, and follow-up after lead removal, with continuous monitoring of vascular and neuropathy-related outcomes.

Diabetic Neuropathy in Spinal Cord Stimulator Patients