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SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease

RecruitingNAAges 19 Years - 89 YearsAllUniversity of Nebraska
NCT06480786 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Peripheral arterial disease (PAD) affects over 230 million adults worldwide and is a highly morbid, costly, and disabling condition. Ischemic leg pain drives disability in PAD patients and results from oxygen supply-demand mismatch, autonomic dysfunction, and muscle breakdown. This leg pain, which is unresponsive to traditional pharmacotherapy, limits the patient's tolerance to exercise, which is an important disease-modifying intervention. Spinal cord stimulation is a well-established therapy for medically intractable pain, including painful diabetic neuropathy (PDN) and ischemic pain, but is not part of the standard-of-care for PAD despite limited promising clinical data. Early studies used first-generation, tonic stimulation devices, but with these it was impossible to perform sham-controlled trials to test the treatment. Since then, new types of waveform treatments, including high-fr

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📋 Eligibility rules (as published)
Inclusion Criteria: * 19 years to 89 years old * Diagnosed diabetes mellitus * Signs or symptoms of neuropathy and maximum baseline visual-analog pain scale ≥ 5 cm and peripheral arterial disease (diagnosed by ankle-brachial index \< 0.90 or vascular imaging studies) with claudication and exertion-induced visual-analog pain scale ≥ 6 cm for a minimum of 3 months * Successful spinal cord stimulator (SCS) trial (\>50% relief of chronic lower extremity pain) and will have a new permanent SCS placed prior to study intervention Exclusion Criteria: * Uncontrolled psychological or psychiatric disorder * Inability to hold antithrombotic therapy per the American Society of Regional Anesthesia guidelines * Non-healing wounds * Gangrene * Critical limb ischemia * Prior lower extremity amputation * Inability to adhere to study follow-up * Mechanical spine instability based on flexion/extension radiographs of the lumbar spine * Prior or current spinal cord stimulator implant
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What it tests

  • Spinal cord stimulation
  • Sham stimulation
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Where

1 site
University of Nebraska Medical Center
Omaha, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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