NCT06480786 SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease
| NCT ID | NCT06480786 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nebraska |
| Condition | Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-12-18 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2024-12-18 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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-frequency spinal cord stimulation (SCS), have been shown to be more effective in the treatment of intractable pain. While high-frequency SCS is approved for PDN treatment, it has never been tested in the treatment of claudication pain from PAD. This study will enroll up to 15 participants between the ages of 19 and 89 who have PAD and PDN and are successfully implanted with a permanent SCS. Twelve weeks after SCS implantation, participants will receive two weeks of stimulation and two weeks of sham intervention, in random starting order. Blood flow, blood pressure, skin oxygen levels, and participant reported pain int the lower extremities will be assessed before SCS implantation, 12 weeks after SCS implantation and during each of the treatment periods. Participants will also complete a quality of life survey at the same time points. Comparisons of these measurements with the baseline and post-implantation measurements to determine the effects of SCS.
Eligibility Criteria
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
Contact & Investigator
Peter Pellegrino, MD
PRINCIPAL INVESTIGATOR
University of Nebraska
Frequently Asked Questions
Who can join the NCT06480786 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 89 Years, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06480786 currently recruiting?
Yes, NCT06480786 is actively recruiting participants. Contact the research team at outcomesresearch@unmc.edu for enrollment information.
Where is the NCT06480786 trial being conducted?
This trial is being conducted at Omaha, United States.
Who is sponsoring the NCT06480786 clinical trial?
NCT06480786 is sponsored by University of Nebraska. The principal investigator is Peter Pellegrino, MD at University of Nebraska. The trial plans to enroll 15 participants.