SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease
NCT Number: NCT06480786
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Peripheral Arterial Disease|Painful Diabetic Neuropathy|Diabetes Mellitus, Type 2|Chronic Pain|Spinal Cord Stimulation|Chronic Pain Syndrome|Limb Pain
Interventions: DEVICE: Spinal cord stimulation|DEVICE: Sham stimulation
Sponsor: University of Nebraska
Collaborators: Nevro Corp
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-12
Locations: University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States

Summary:
The study involves permanent spinal cord stimulator (SCS) placement in participants with peripheral arterial disease (PAD) and painful diabetic neuropathy (PDN). Participants will be between 19 and 90 years old, have diabetes with symptoms of neuropathy, and have a starting pain level of at least 5 cm on a visual pain scale. They must also have PAD, confirmed by an ankle-brachial index under 0.90 or vascular imaging, and experience pain from walking with a pain level of at least 6 cm for at least 3 months. Their Vascular Quality of Life Questionnaire score should be 5.5 or less, and they must be good candidates for SCS.

The study includes initial evaluation visits, follow up after their permanent SCS is placed and optimized 12 weeks in the clinic at this time the study interventions begin and the patient is followed for four weeks; two weeks of stimulation and two weeks of sham intervention in random order, and intervention evaluations. At each follow up visit pain, sensory, functional, vascular, and autonomic outcomes will be assessed, after which patients will return to standard SCS care. The total time for the study intervention is 4 weeks.

Primary Outcome Measures: High-frequency spinal cord stimulation (SCS) effect on analgesia, The hypothesis will test that high-frequency spinal cord stimulation (SCS) improves analgesia by measuring Visual Analogue Scale (VAS) scores during interventions. The VAS score is a10-cm line that represents a continuum between "no pain" and "worst pain.", baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2
Secondary Outcome Measures: High-frequency spinal cord stimulation (SCS) effect on quality of life, The hypothesis will be tested that high-frequency SCS improves quality of life by measuring Vascular Quality of Life Questionnaire (VASCUQOL). VASCUQOL is 25 questions asked about how the patient has been affected by poor circulation in your legs in the past two weeks., baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2|High-frequency spinal cord stimulation (SCS) effect on blood flow, The hypothesis will be tested that high-frequency SCS improves blood flow by measuring lower extremity capillary digit blood flow flow by laser speckle imaging., baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2|High-frequency spinal cord stimulation (SCS) effect on automonic control, The hypothesis will be tested that high-frequency SCS improves automonic control by measuring sympathetic vasomotion., baseline, 12 week follow up after permanent spinal cord simulator, week 14 intervention #1 , week 16 intervention #2